Systems and methods for performing cardiac resynchronization therapy (crt) using leadless pacemakers

ABSTRACT

Embodiments of the present technology described herein are directed to implantable systems for performing cardiac resynchronization therapy (CRT), methods for use therewith, and leadless pacemakers for use therewith. Such a system can include a first leadless pacemaker configured to be implanted in or on the right atrial (RA) chamber and selectively pace the RA chamber, a second leadless pacemaker configured to be implanted in or on the right ventricular (RV) chamber and selectively pace the RV chamber, and a third leadless pacemaker configured to be implanted in or on the left ventricular (LV) chamber and selectively pace the LV chamber, wherein one of the leadless pacemaker is designated a master leadless pacemaker. In certain embodiments, the master leadless pacemaker determines a VV delay and an AV delay and coordinates CRT using such delays.

FIELD OF TECHNOLOGY

Embodiments of the present technology generally relate to methods,systems and devices that can be used to provide CardiacResynchronization Therapy (CRT), and can be used to select CRTparameters.

BACKGROUND

Heart failure (HF) is a debilitating, end-stage disease in whichabnormal function of the heart leads to inadequate blood flow to fulfillthe needs of the body's tissues. Typically, the heart loses propulsivepower because the cardiac muscle loses capacity to stretch and contract.Often, the ventricles do not adequately fill with blood betweenheartbeats and the valves regulating blood flow may become leaky,allowing regurgitation or backflow of blood. The impairment of arterialcirculation deprives vital organs of oxygen and nutrients. Fatigue,weakness, and inability to carry out daily tasks may result.

Not all HF patients suffer debilitating symptoms immediately. Some maylive actively for years. Yet, with few exceptions, the disease isrelentlessly progressive. As HF progresses, it tends to becomeincreasingly difficult to manage. Even the compensatory responses ittriggers in the body may themselves eventually complicate the clinicalprognosis. For example, when the heart attempts to compensate forreduced cardiac output, it adds muscle causing the ventricles to grow involume in an attempt to pump more blood with each heartbeat. This placesa still higher demand on the heart's oxygen supply. If the oxygen supplyfalls short of the growing demand, as it often does, further injury tothe heart may result. The additional muscle mass may also stiffen theheart walls to hamper rather than assist in providing cardiac output.

Some treatments for HF are centered around medical treatment using ACEinhibitors, diuretics and/or digitalis. It has also been demonstratedthat aerobic exercise may improve exercise tolerance, improve quality oflife, and decrease symptoms. Cardiac surgery has also been performed ona small percentage of patients with particular etiologies. Althoughadvances in pharmacological therapy have significantly improved thesurvival rate and quality of life of patients, some HF patients arerefractory to drug therapy, have a poor prognosis and limited exercisetolerance. In recent years cardiac pacing, in particular CardiacResynchronization Therapy (CRT), has emerged as an effective treatmentfor many patients with drug-refractory HF.

While CRT does not work for all HF patients, a majority of HF patientsare CRT responders, meaning that CRT can be used to improve thosepatients' HF condition. CRT pacing parameters are preferablyindividualized for patients to increase CRT benefits.

While echocardiography based techniques are sometimes used to select CRTpacing parameters, echocardiography based CRT pacing parameter selectionis very time consuming and poorly reproducible. Device based CRTparameter selection algorithms have alternatively been used to selectCRT pacing parameters, including atrioventricular (AV) delay andinterventricular (VV) delay. For example, St. Jude Medical's QuickOpt™algorithm can be used to select AV and VV delays based on measures froman intra-cardiac electrogram (IEGM) or electrocardiogram (ECG), such asP-wave width, which is also known as P-wave duration.

CRT is conventionally performed using a conventional pacemaker that isimplanted in a pectoral region of a patient. The pacemaker typicallyincludes a housing (also known as a “can” or “case”) from which extendthree leads implanted into a patient's heart for deliveringmulti-chamber cardiac pacing and sensing. The three leads can include aright atrial (RA) lead, a right ventricular (RV) lead, and a leftventricular (LV) lead. The RA lead can be used to provide atrial chamberpacing stimulation and sensing and may include, for example, an atrialtip electrode and an atrial ring electrode implanted in the atrialappendage. The RV lead may include, for example, a ventricular tipelectrode, a RV ring electrode, a RV coil electrode, and a superior venacava (SVC) coil electrode. Typically, the RV lead is transvenouslyinserted into the heart so as to place the RV coil electrode in the RVapex, and the SVC coil electrode in the superior vena cava. Accordingly,the RV lead is capable of receiving cardiac signals, and deliveringstimulation in the form of pacing (and potentially shock therapy) to theright ventricle (also referred to as the RV chamber). The LV lead can beused to sense left atrial and ventricular cardiac signals and to provideleft chamber pacing therapy. The LV lead can be a multi-pole LV leaddesigned for placement in the “CS region” via the CS os for positioninga distal electrode adjacent to the left ventricle and/or additionalelectrode(s) adjacent to the left atrium (also referred to as the LAchamber). As used herein, the phrase “CS region” refers to the venousvasculature of the left ventricle, including any portion of the CS,great cardiac vein, left marginal vein, left posterior ventricular vein,middle cardiac vein, and/or small cardiac vein or any other cardiac veinaccessible by the CS. An example of an LV lead is the Quartet™quadripolar LV lead available from Abbott Cardiovascular (headquarteredin St. Paul, Minn.).

When a conventional pacemaker is used to perform CRT, a controller(e.g., processor) that is located within the housing of the pacemakercan obtain sensed signals from electrodes of all three of the leadsphysically connected to the pacemaker. Further, the controller (e.g.,processor) that is located within the housing of the pacemaker canprovide instructions to one or more pulse generators and electrodeconfiguration switches to control the timing and stimulation vectorsused to deliver cardia therapy.

Recently there has been an increased interest in using leadlesspacemakers (LPs) to deliver cardiac therapy. LPs offer an alternative totraditional pacemakers by eliminating the need for transvenous leads.Further, LPs do not require a creation of a surgical pocket on thechest. When an LP is in place, there is no lump under the skin on thechest or leads anchored to the muscle bed, Further, LPs avoid certaincomplications associated with conventional pacemakers, including pocketcomplications such as pocket hematoma, infection, erosion, migration ofthe pacemaker, and Twiddler's syndrome. Additionally, LPs avoidlead-related complications such as lead dislodgement, pneumothorax,loose connector pin, conductor coil (lead) fracture, and insulationbreak.

LPs have been successfully implanted in the right ventricle (RV) chamberof patients to provide single chamber sensing and pacing. Dual chamberLP systems have also been proposed wherein a first LP is implanted inthe RV chamber and a second LP is implanted in the RA chamber to providefor dual chamber pacing. Depending upon the specific type of pacingneeded, where a patient includes LPs implanted in the RA and RVchambers, the two LPs need to communicate with one another to provideappropriate timed atrioventricular (AV) delays. Implant-to-implant (i2i)communications can be used by the two LPs to communicate with oneanother to achieve desired AV synchrony.

Since leadless pacemaker (LP) systems provide certain benefits overconventional pacemaker systems that include leads, it would bebeneficial if LP systems could be used to perform CRT. An LP system thatis capable of performing CRT may include three LPs, including an LPcapable of pacing the RV chamber, an LP capable of pacing the LVchamber, and an LP capable of pacing the RA chamber. However, incontrast to conventional pacemakers, LP systems do not include a singlecontroller (e.g., processor) located within the housing of the pacemakerto obtain sensed signals from electrodes of three leads physicallyconnected to the pacemaker. Further, in contrast to conventionalpacemakers, LP systems do not include a single controller (e.g.,processor) located within the housing of the pacemaker that providesinstructions to pulse generators and electrode configuration switcheswithin the housing of the pacemaker to control the timing andstimulation vectors used to deliver cardia therapy. Accordingly there isa need to provide LP systems, and methods for use therewith, that canperform CRT using three physically separated LPs.

SUMMARY

Certain embodiments of the present technology are related to methods forperforming cardiac resynchronization therapy (CRT) using an implantableleadless pacemaker system including a first leadless pacemaker (LP1)implanted in or on the right atrial (RA) chamber, a second leadlesspacemaker (LP2) implanted in or on the right ventricular (RV) chamber,and a third leadless pacemaker (LP3) implanted in or on the leftventricular (LV) chamber, wherein one of the LP1, the LP2, or the LP3 isdesignated a master LP. For example, in certain embodiments, the LP2that is implanted in or on the RV chamber is designated the master.

In accordance with certain embodiments, a method includes the LP1, whichis implanted in or on the RA chamber, measuring a P-wave duration basedon a signal sensed by the LP1. The LP1, which is implanted in or on theRA chamber, or another one of the LPs that is designated the master LP,determines an atrio-ventricular (AV) delay based on the measured P-waveduration. The LP2, which is implanted in or on the RV chamber, oranother one of the LPs that is designated the master LP, determines afirst AR or PR interval indicative of a time between an atrialdepolarization and a ventricular depolarization in the RV chamber. TheLP3, which is implanted in or on the LV chamber, or another one of theLPs that is designated the master LP, determines a second AR or PRinterval indicative of a time between an atrial depolarization and aventricular depolarization in the LV chamber. When determining the firstand second PR intervals, the time at which an atrial depolarization isconsidered to occur can be, e.g., a beginning, a peak, or an end aP-wave (so long as this is done consistently for both the first andsecond PR intervals); and the time at which a ventricular depolarizationis considered to occur is preferably when a peak of an R-wave or QRScomplex occurs. In other words, where an atrial event (i.e., an atrialdepolarization) is sensed, a time at which the atrial event isconsidered to occur can be, e.g., at a beginning, a peak, or an end of aP-wave, so long as the way this is achieved is consistent. Preferably,the time at which a ventricular event is considered to occur in the RVchamber is at a peak of an R-wave or QRS complex of an EGM indicative ofelectrical activity in the RV chamber, and a time at which a ventricularevent is considered to occur in the LV chamber is at a peak of an R-waveor ORS complex of an EGM indicative of electrical activity in the LVchamber.

The one of the LPs that is designated the master LP determines a deltaindicative of a difference between the first AR or PR interval and thesecond AR or PR interval. The LP2, which is implanted in or on the RVchamber, paces the RV chamber, and at least one of the LPs determines anRV-LV delay indicative of a time it takes for a ventriculardepolarization in the RV chamber to propagate to the LV chamber. TheLP3, which is implanted in or on the LV chamber, paces the LV chamber,and at least one of the LPs determines an LV-RV delay indicative of atime it takes for a ventricular depolarization in the LV chamber topropagate to the RV chamber. The method also includes the one of the LPsthat is designated the master LP determining a correction factorindicative of a difference between the LV-RV delay and the RV-LV delay,and determining a VV delay based on the determined delta and thedetermined correction factor. The LP1, the LP2, and the LP3 collectivelyperform CRT using the determined AV delay and the determined VV delay.

In accordance with certain embodiments, the measuring the P-waveduration occurs during a first set of cardiac cycles comprising one ormore cardiac cycles; the determining the first AR or PR interval duringa second set of cardiac cycles comprising one or more cardiac cyclesthat may or may not overlap with the first set of cardiac cycles; thedetermining the second AR or PR interval occurs during a third set ofcardiac cycles comprising one or more cardiac cycles that may or may notoverlap with the first and/or second set of cardiac cycles; the pacingthe RV chamber and the determining the RV-LV delay occurs during afourth set of cardiac cycles comprising one or more cardiac cycles thatdo not overlap with any of the first, second, and third sets of cardiaccycles; and the pacing the LV chamber and the determining the LV-RVdelay occurs during a fifth set of cardiac cycles comprising one or morecardiac cycles that do not overlap with any of the first, second, third,and fourth sets of cardiac cycles.

In accordance with certain embodiments, when the AV delay is for use inpacing during one or more cardiac cycles that start with an intrinsicatrial event, the determining the AV delay based on the measured P-waveduration, comprises: setting the AV delay to the P-wave duration plus afirst offset, in response to the P-wave duration being greater than athreshold duration; and setting the AV delay to the P-wave duration plusa second offset that is greater than the first offset, in response tothe P-wave duration being less than the threshold duration. It is alsowithin the scope of the embodiments described herein to use some othermeasure of inter-atrial conduction delay (IACD), besides P-waveduration, to determine the AV delay.

In accordance with certain embodiments, when the AV delay is for use inpacing during one or more cardiac cycles that start with a paced atrialevent, the determining the AV delay based on the measured P-waveduration, comprises: setting the AV delay to the P-wave duration plus athird offset, in response to the P-wave duration being greater than asecond threshold duration; and setting the AV delay to the P-waveduration plus a fourth offset that is greater than the third offset, inresponse to the P-wave duration being less than the second thresholdduration.

In accordance with certain embodiments, the one of the LPs that isdesignated the master LP determines the VV delay as being equal to halfof a sum of the determined delta plus the determined correction factor.

In accordance with certain embodiments, the LP1, the LP2, and the LP3collectively performing CRT using the determined AV delay and thedetermined VV delay, comprises: the LP2, determining on its own or basedon an i2i message received from the LP1, when an atrial paced or sensedevent occurs; and the LP3, determining on its own or based on an i2imessage received from the LP1, when the atrial paced or sensed eventoccurs. If the VV delay is negative, then the LP3 can pace the LVchamber at the AV delay following when the atrial paced or sensed eventoccurs, and then the LP2 can pace the RV chamber at the VV delayfollowing when the LP3 paces the LV chamber; and if the VV delay ispositive, then the LP2 can pace the RV chamber at the AV delay followingwhen the atrial paced or sensed event occurs, and then the LP3 can pacethe LV chamber at the VV delay following when the LP2 paces the RVchamber. Alternatively, if the VV delay is negative, then the LP3 canpace the LV chamber at the AV delay following when the atrial paced orsensed event occurs, and then the LP2 can pace the RV chamber at a delayequal to a sum of the AV delay plus the VV delay following when theatrial paced or sensed event occurs; and if the VV delay is positive,then the LP2 can pace the RV chamber at the AV delay following when theatrial paced or sensed event occurs, and then the LP3 can pace the LVchamber at the delay equal to a sum of the AV delay plus the VV delayfollowing when the atrial paced or sensed event occurs.

In accordance with certain embodiments, the method further includes theLP1 pacing the RA chamber at a VA delay following when the LP2 paces theRV chamber or the LP3 paces the LV chamber.

Certain embodiments of the present technology are related to implantablesystems for performing CRT. Such a system can include a first leadlesspacemaker (LP1) configured to be implanted in or on the RA chamber andselectively pace the RA chamber; a second leadless pacemaker (LP2)configured to be implanted in or on the RV chamber and selectively pacethe RV chamber; and a third leadless pacemaker (LP3) configured to beimplanted in or on the LV chamber and selectively pace the LV chamber,wherein one of the LPI, the LP2, or the LP3 is designated a master LP.The LP1 is also configured to sense a signal and measure a P-waveduration based on the signal sensed by the LP1. The LP1, or another oneof the LPs that is designated the master LP, is configured to determinean AV delay based on the measured P-wave duration. The LP2, or anotherone of the LPs that is designated the master LP, is configured todetermine a first AR or PR interval indicative of a time between anatrial depolarization and a ventricular depolarization in the RVchamber. The LP3, or another one of the LPs that is designated themaster LP, is configured to determine a second AR or PR intervalindicative of a time between an atrial depolarization and a ventriculardepolarization in the LV chamber. At least one of the LPs is configuredto determine an RV-LV delay indicative of a time it takes for aventricular depolarization in the RV chamber to propagate to the LVchamber in response to the LP2 pacing the RV chamber. In accordance withcertain embodiments, a time at which a ventricular depolarization in theRV chamber is considered to have propagated to the LV chamber is at apeak of an R-wave or QRS complex detected by the LP3 implanted withinthe LV chamber. At least one of the LPs is configured to determine anLV-RV delay indicative of a time it takes for a ventriculardepolarization in the LV chamber to propagate to the RV chamber inresponse to the LP3 pacing the LV chamber. In accordance with certainembodiments, a time at which a ventricular depolarization in the LVchamber is considered to have propagated to the RV chamber is at a peakof an R-wave or QRS complex detected by the LP2 implanted within the RVchamber. The one of the LPs that is designated the master LP isconfigured to determine a delta indicative of a difference between thefirst AR or PR interval and the second AR or PR interval, determine acorrection factor indicative of a difference between the LV-RV delay andthe RV-LV delay, and determine a VV delay based on the determined deltaand the determined correction factor. The LP1, the LP2, and the LP3 areconfigured to collectively perform CRT using the determined AV delay andthe determined VV delay.

In accordance with certain embodiments, the LP1, which is configured tobe implanted in or on the RA chamber, is configured to measure theP-wave duration during a first set of cardiac cycles comprising one ormore cardiac cycles; the LP2, which is configured to be implanted in oron the RV chamber, is configured to determine the first AR or PRinterval during a second set of cardiac cycles comprising one or morecardiac cycles that may or may not overlap with the first set of cardiaccycles; the LP3, which is configured to be implanted in or on the LVchamber, is configured to determine the second AR or PR interval duringa third set of cardiac cycles comprising one or more cardiac cycles thatmay or may not overlap with the first and/or second set of cardiaccycles; the LP2 is also configured to determine the RV-LV delay during afourth set of cardiac cycles comprising one or more cardiac cycles thatdo not overlap with any of the first, second, and third sets of cardiaccycles; and the LP3 is also configured to determine the LV-RV delayduring a fifth set of cardiac cycles comprising one or more cardiaccycles that do not overlap with any of the first, second, third, andfourth sets of cardiac cycles.

In accordance with certain embodiments, when the AV delay is for use inpacing during one or more cardiac cycles that start with an intrinsicatrial event, the LP that is designated the master is configured to: setthe AV delay to the P-wave duration plus a first offset, in response tothe P-wave duration being greater than a threshold duration; and set theAV delay to the P-wave duration plus a second offset that is greaterthan the first offset, in response to the P-wave duration being lessthan the threshold duration.

In accordance with certain embodiments, when the AV delay is for use inpacing during one or more cardiac cycles that start with a paced atrialevent, the LP that is designated the master is configured to: set the AVdelay to the P-wave duration plus a third offset, in response to theP-wave duration being greater than a second threshold duration; and setthe AV delay to the P-wave duration plus a fourth offset that is greaterthan the third offset, in response to the P-wave duration being lessthan the second threshold duration.

In accordance with certain embodiments, the LP that is designated themaster LP is configured to determine the VV delay as being equal to halfof a sum of the determined delta plus the determined correction factor.

In accordance with certain embodiments, the LP1, the LP2, and the LP3are configured to collectively performing CRT using the determined AVdelay and the determined VV delay, and wherein: the LP2 is configured todetermine on its own or based on an i2i message received from the LP1,when an atrial paced or sensed event occurs; and the LP3 is configuredto determine on its own or based on an i2i message received from theLP1, when the atrial paced or sensed event occurs. When the VV delay isnegative, the LP3 is configured to pace the LV chamber at the AV delayfollowing when the atrial paced or sensed event occurs, and the LP2 isconfigured to pace the RV chamber at the VV delay following when the LP3paces the LV chamber. When the VV delay is positive, the LP2 isconfigured to pace the RV chamber at the AV delay following when theatrial paced or sensed event occurs, and the LP3 is configured to pacethe LV chamber at the VV delay following when the LP2 paces the RVchamber.

In accordance with certain embodiments, the one of the LPs that isdesignated the master LP is configured to orchestrate the CRT that iscollectively performed by the LP1, the LP2, and the LP3 using thedetermined AV delay and the determined VV delay.

In accordance with certain embodiments, the LP1, which is configured tobe implanted in or on the RA chamber, is configured to pace the RAchamber at a VA delay following when the LP2 paces the RV chamber or theLP3 paces the LV chamber.

In accordance with certain embodiments, the LP2, which is configured tobe implanted in or on the RV chamber, is designated the master LP.

Certain embodiments of the present technology are directed to a leadlesspacemaker (rvLP) configured to be implanted in or on a right ventricular(RV) chamber and configured to perform cardiac resynchronization therapy(CRT) along with a leadless pacemaker (raLP) configured to be implantedin or on a right atrial (RA) chamber and a leadless pacemaker (lvLP)configured to be implanted in or on the left ventricular (LV) chamber.In such embodiments, the rvLP comprises one or more pulse generators, aplurality of electrodes, and a controller. The one or more pulsegenerators is/are configured to selectively produce pacing pulses andimplant-to-implant (i2i) communication pulses, the pacing pulses for usein pacing the RV chamber, and the i2i communication pulses for use insending i2i messages to at least one of the raLP or the lvLP. At leasttwo of the electrodes can be used to deliver one or more pacing pulsesto the RV chamber; at least two of the electrodes can be used totransmit and receive one or more i2i communication pulses to and from atleast one of the raLP or the lvLP; and at least two of the electrodescan be used to sense a far-field signal from which cardiac activityassociated with at least one of the RA or LV chambers may be detected.The controller is configured to determine: an atrio-ventricular (AV)delay based on a P-wave duration measurement received via one or morei2i communication pulses from the raLP; an RV-LV delay indicative of atime it takes for a ventricular depolarization in the RV chamber topropagate to the LV chamber in response to the rvLP pacing the RVchamber; an LV-RV delay indicative of a time it takes for a ventriculardepolarization in the LV chamber to propagate to the RV chamber inresponse to the lvLP pacing the LV chamber; a delta indicative of adifference between a first AR or PR interval and a second AR or PRinterval; a correction factor indicative of a difference between theLV-RV delay and the RV-LV delay; and a VV delay based on the determineddelta and the determined correction factor. The controller is alsoconfigured to coordinate performance of CRT collectively by the rvLP,the raLP, and the lvLP using the determined AV delay and the determinedVV delay, as well as using a VA delay.

This summary is not intended to be a complete description of theembodiments of the present technology. Other features and advantages ofthe embodiments of the present technology will appear from the followingdescription in which the preferred embodiments have been set forth indetail, in conjunction with the accompanying drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present technology relating to both structure andmethod of operation may best be understood by referring to the followingdescription and accompanying drawings, in which similar referencecharacters denote similar elements throughout the several views:

FIG. 1A illustrates a system formed in accordance with certainembodiments described herein as implanted in and/or on a heart.

FIG. 1B is a block diagram of an exemplary leadless pacemaker (LP) inaccordance with certain embodiments herein.

FIG. 2 illustrates an LP in accordance with certain embodiments herein.

FIG. 3 is a timing diagram demonstrating one embodiment of implant toimplant (i2i) communication for a paced event.

FIG. 4 is a timing diagram demonstrating one embodiment of i2icommunication for a sensed event.

FIGS. 5A and 5B illustrate exemplary LPs that enables the LPs toeffectively deliver pacing pulses to the cardiac chamber within or onwhich the LP is implanted, effectively sense near-field signals, as wellas effectively sense far-field signals.

FIG. 6 is a high level flow diagram that is used to describe certainembodiments of the present technology for performing cardiacresynchronization therapy (CRT) using an implantable leadless pacemakersystem including an LP implanted in or on the RA chamber, an LPimplanted in or on the RV chamber, and an LP implanted in or on the LVchamber, wherein one of the LPs is designated a master LP.

FIG. 7A is a flow diagram that is used to provide additional details ofone of the steps introduced in FIG. 6.

FIGS. 7B and 7C are flow diagrams that are used to provide additionaldetails of one of the steps introduced in FIG. 7A.

FIG. 8 is a flow diagram that is used to provide additional details ofanother one of the steps introduced in FIG. 6.

FIG. 9 is a flow diagram that is used to provide additional details ofstill another one of the steps introduced in FIG. 6.

FIG. 10 is a flow diagram that is used to provide additional details ofa further one of the steps introduced in FIG. 6.

FIG. 11 shows a block diagram of an embodiment of an LP that isimplanted into a patient as part of an implantable cardiac system inaccordance with certain embodiments herein.

DETAILED DESCRIPTION

Certain embodiments of the present technology relate to implantablesystems, and methods for use therewith, that can be used to performcardiac synchronization therapy (CRT). For example, certain embodimentsof the present technology relate to implantable systems, and methods foruse therewith, that can be used perform DDD or DDI pacing using threeLPs, wherein one of the LPs (LP1) is implanted in (or on) a patient's RAchamber, one of the LPs (LP2) is implanted in (or on) the patient's RVchamber, and one of the LPs (LP3) is implanted in (or on) the patient'sLA chamber. More specifically, in accordance with certain embodiments ofthe present technology, the LP1 implanted in (or on) a patient's RAchamber and is used to perform ADD pacing, the LP2 implanted in (or on)the patient's RV chamber is used to perform VDD pacing, and the LP3implanted in (or on) the patient's LV chamber is used to perform VDDpacing. Collectively, the LP1, the LP2, and the LP3 in such anembodiment performs DDD or DDI pacing or some other tri-chamber pacingmode that provides synchronization between the LP1, the LP2, and theLP3. Where LPs are said to be synchronized or have synchronizationprovided, this means that the pacing performed by at least one of theLPs is timed relative to paced events delivered by and/or sensed eventssensed by the other LPs. Accordingly, two LPs can be said to besynchronized where there is VA synchrony but not AV synchrony, VAsynchrony but not AV synchrony, or both VA and AV synchrony

Any one of various different algorithms can be used to achieve such dualchamber pacing modes. When referring to various types of pacing schemesherein, three letters are often used to refer to the type of pacing. Inother words, a three position pacemaker code is often used, with thefollowing nomenclature followed: the first position refers to thecardiac chamber paced; the second position refers to the cardiac chambersensed; and the third position refers to the response to a sensed event.In the first and second positions, the letter O means none, the letter Ameans Atrium, the letter V means Ventricle, and the letter D means Dual(i.e., A and V). In the third position the letter O means none, theletter I means Inhibited, the letter T means Triggered (aka Tracked),and the letter D means Dual (i.e., T+I). The below Table 1 summarizesthis pacemaker nomenclature.

TABLE 1 Position 1 Position 2 Position 3 (Chamber Paced) (ChamberSensed) (Response to Sensed Event) O = none O = none O = none A = AtriumA = Atrium I = Inhibited V = Ventricle V = Ventricle T = Triggered (akaTracked) D = Dual (A + V) D = Dual (A + V) D = Dual (I + T)

Accordingly, if an LP in the patient's RV chamber performs VDD pacing,that means it paces only the RV chamber, senses both atrial andventricular activity, and inhibits pacing of the RV if a sensed event isdetected within a specified interval (the AV interval) or triggerspacing of the RV at the end of the specified interval (the AV interval)if a sensed event is not detected within that specified interval (the AVinterval). For another example, if an LP in the patient's RA chamberperforms AAI pacing, that means it paces only the RA chamber, sensesonly atrial activity, and inhibits pacing of the RA chamber if a sensedevent is detected within a specified interval. Where the second positionincludes a “0”, the LP will need to be aware of activity in its ownchamber and in another chamber in or one which the LP is not implanted.Activity in another chamber can be determined from a far-field signaland/or from an i2i message received from another LP that is in or onethe other chamber.

When an LP in (or on) the RV or LV chamber performs VDD pacing, itshould know when certain cardiac activity (e.g., atrial contractions)occur in the RA chamber, so that it knows the appropriate times at whichto pace the RV or LV chamber.

Before providing addition details of the specific embodiments of thepresent technology mentioned above, as well as additional embodiments ofthe present technology, an exemplary system in which embodiments of thepresent technology can be used will first be described with reference toFIGS. 1A, 1B, and 2. More specifically, FIGS. 1A, 1B, and 2 will be usedto describe an exemplary cardiac pacing system, wherein pacing andsensing operations can be performed by multiple medical devices, whichinclude three LPs, an optional implantable cardioverter-defibrillator(ICD), such as a subcutaneous-ICD, and/or a programmer reliably andsafely coordinate pacing and/or sensing operations. In certainembodiments, described in more detail below, one of the LPs isdesignated the master LP, with the other two LPs being slave LPs.

FIG. 1A illustrates a system 100 formed in accordance with certainembodiments herein as implanted in and/or on a heart 101. The system 100comprises three LPs 102 a, 102 b and 102 c located in or on differentchambers of the heart. LP 102 a is located in the RA chamber, while LP102 b is located in the RV chamber, and the LP 102 c is located in theLV chamber. The LPs 102 a, 102 b, and 102 c can be referred tocollectively as the LPs 102, or individually as an LP 102. The LPs 102can communicate with one another to inform one another of various localphysiologic activities, such as local intrinsic events, local pacedevents and the like. The LPs 102 a, 102 b and 102 c may be constructedin a similar manner, but operate differently based upon which chamberthe LP is located. It is noted that the RA chamber is also known as theright atrium, and the acronym RA can be used to refer to the “rightatrium” or to refer to the “right atrial” chamber. Similarly, the RVchamber is also known as the right ventricle, and the acronym RV can beused to refer to the “right ventricle” or to refer to the “rightventricular” chamber. Further, the LV chamber is also known as the leftventricle, and the acronym LV can be used to refer to the “leftventricle” or to refer to the “left ventricular” chamber. It is alsonoted that the terms “cardiac chamber”, “chamber of the heart”, and“chamber of a patient's heart” are used interchangeably herein.

In accordance with certain embodiments, the LP 102 a is used to performADD pacing, each of the LPs 102 b and 102 c is used to perform VDDpacing, and the LPs 102 a, 102 b and 102 c are collectively used toperform DDD pacing. The ADD pacing (performed by the LP 102 a) involvesatrial pacing, ventricular and atrial (i.e., dual) sensing, and dual(i.e., triggered and inhibited) response to a sensed event. The VDDpacing (performed by the LPs 102 b and 102 c) involves ventricularpacing, atrial and ventricular (i.e., dual) sensing, and dual (i.e.,triggered and inhibited) response to a sensed event. The DDD pacing(performed collectively by the LPs 102 a, 102 b and 102 c) involvesatrial and ventricular (i.e., dual) pacing, atrial and ventricular(i.e., dual) sensing, and dual (i.e., triggered and inhibited) responseto a sensed event.

In some embodiments, all (or at least some) of the LPs 102 a, 102 b and102 c communicate with one another, with an ICD 106, and with anexternal device (e.g., programmer) 109 through wireless transceivers,communication coils and antenna, and/or by conductive communicationthrough the same electrodes as (or one or more different electrodesthan) used for sensing and/or delivery of pacing therapy. Whenconductive communication is performed using electrodes, the system 100may omit an antenna or telemetry coil in one or more of the LPs 102.

In some embodiments, one or more LPs 102 can be co-implanted with theICD 106. Each LP 102 uses two or more electrodes located within, on, orwithin a few centimeters of the housing of the LP, for pacing andsensing at the cardiac chamber, for bidirectional communication with atleast one other LP, the programmer 109 (or some other external device),and the ICD 106.

In FIG. 1A, the LPs 102 a, 102 b and 102 c are shown as being implantedendocardially, i.e., within respective cardiac chambers. In other words,in FIG. 1A each of the LPs 102 is shown as being implanted in arespective cardiac chamber, i.e., the LP 102 a is shown as beingimplanted in the RA chamber, the LP 102 b is shown as being implanted inthe RV chamber, and the LP 102 c is shown as being implanted in the LVchamber. Alternatively, one or more of the LPs 102 can be implantedepicardially (on the external heart surface) by affixing to the exteriorsurface of the heart. For example, it would also be possible for the LP102 a to be affixed to an exterior surface of the RA chamber, in whichcase the LP 102 a can be said to be implanted on (rather than in) the RAchamber. Similarly, it would also be possible for the LP 102 b to beaffixed to an exterior of the RV chamber, in which case the LP 102 b canbe said to be implanted on (rather than in) the RV chamber. Further, itwould also be possible for the LP 102 c to be affixed to an exterior ofthe LV chamber, in which case the LP 102 c can be said to be implantedon (rather than in) the LV chamber. More specifically, the LP 102 c canbe affixed to an exterior of the LV chamber using a minimally invasiveprocedure such that the LP 102 c is located within the pericardial sac.It would also be possible to implant the LP 102 c in the coronary sinusproximate the LV chamber. Alternatively, if the LP 102 c is made smallenough, the LP 102 c can be implanted through the great vein.

More generally, an LP 102 can either be implanted in or on the cardiacchamber that the LP is being used to pace. It is noted that the terms“implanted in,” “implanted within,” “located in,” and “located within”are used interchangeably herein when referring to where a particular LPis implanted. Further, it is noted that the terms “located on” and“implanted on” are used interchangeably herein when referring to where aparticular LP is implanted. The cardiac chamber within or on which aparticular LP is implanted can be referred to as a “local chamber”,while another chamber (within or on which the particular LP is notimplanted) can be referred to as a “remote chamber”.

In accordance with certain embodiments, methods are provided forcoordinating operation between LPs located in or on different cardiacchambers of the heart. Some such methods can configure a local LP toreceive communications from a remote LP through conductivecommunication. Some such methods rely on a local LP sensing a far-fieldsignal and/or a sensor signal to itself monitor cardiac activityassociated with a remote cardiac chamber.

Referring to FIG. 1B, a block diagram shows exemplary electronics withinan LP 102. The LP 102 includes first and second receivers 120 and 122that collectively define separate first and second communicationchannels between LPs 102. Although first and second receivers 120 and122 are depicted, in other embodiments, an LP 102 may only include firstreceiver 120, or may include additional receivers other than first andsecond receivers 120 and 122. As will be described in additional detailbelow, the pulse generator 116 can function as a transmitter thattransmits implant-to-implant (i2i) communication signals using theelectrodes 108. Usage of the electrodes 108 for communication enablesthe one or more LPs 102 to perform antenna-less and telemetry coil-lesscommunication.

In accordance with certain embodiments, when one of the LPs 102 sensesan intrinsic event or delivers a paced event, the corresponding LP 102transmits an implant event message to one or more other LP(s) 102. Forexample, when an atrial LP 102 (102 a) senses/paces an atrial event, theatrial LP 102 (102 a) can transmit an implant event message including anevent marker indicative of a nature of the event (e.g., intrinsic/sensedatrial event, paced atrial event). When a ventricular LP 102 (102 b)senses/paces a ventricular event, the ventricular LP 102 (102 b)transmits an implant event message including an event marker indicativeof a nature of the event (e.g., intrinsic/sensed ventricular event,paced ventricular event). In certain embodiments, an LP 102 transmits animplant event message to at least one other LP 102 preceding the actualpace pulse so that the remote LP can blank its sense inputs inanticipation of that remote pace pulse (to prevent inappropriatecrosstalk sensing). Where an implant event message is sent from one LPto another LP, the implant event message can be referred to as animplant-to-implant (i2i) event massage, or more generally, as an i2imessage.

Still referring to FIG. 16, the LP 102 is shown as including acontroller 112 and a pulse generator 116. The controller 112 caninclude, e.g., a microprocessor (or equivalent control circuitry), RAMand/or ROM memory, logic and timing circuitry, state machine circuitry,and I/O circuitry, but is not limited thereto. The controller 112 canfurther include, e.g., timing control circuitry to control the timing ofthe stimulation pulses (e.g., pacing rate, atrio-ventricular (AV) delay,atrial interconduction (A-A) delay, or ventricular interconduction (V-V)delay, etc.). Such timing control circuitry may also be used for thetiming of refractory periods, blanking intervals, noise detectionwindows, evoked response windows, alert intervals, marker channeltiming, and so on. The controller 112 can further include otherdedicated circuitry and/or firmware/software components that assist inmonitoring various conditions of the patient's heart and managing pacingtherapies. The controller 112 and the pulse generator 116 may beconfigured to transmit event messages, via the electrodes 108, in amanner that does not inadvertently capture the heart in the chamberwhere LP 102 is located, such as when the associated chamber is not in arefractory state. In addition, an LP 102 that receives an event messagemay enter an “event refractory” state (or event blanking state)following receipt of the event message. The event refractory/blankingstate may be set to extend for a determined period of time after receiptof an event message in order to avoid the receiving LP 102 frominadvertently sensing another signal as an event message that mightotherwise cause retriggering. For example, the receiving LP 102 maydetect a measurement pulse from another LP 102 or programmer 109.

In accordance with certain embodiments herein, the programmer 109 maycommunicate over a programmer-to-LP channel, with one or more of the LPs102 utilizing the same communication scheme. The external programmer 109may listen to the event message transmitted between LPs 102 andsynchronize programmer to implant communication such that programmer 109does not transmit communication signals until after an implant toimplant messaging sequence is completed. Alternatively, the externalprogrammer 109 may wait for a directed communication message transmittedto the external programmer 109 from an LP 102 that indicates to theexternal programmer 109 that the LP is ready to trade communicationsignals with the external programmer 109. An LP 102 can also communicatewith other types of external devices besides the external programmer109, such as, but not limited to, an external monitor.

In accordance with certain embodiments, an LP 102 may combine transmitoperations with therapy. The transmit event marker may be configured tohave similar characteristics in amplitude and pulse-width to a pacingpulse and an LP 102 may use the energy in the event messages to helpcapture the heart. For example, a pacing pulse may normally be deliveredwith pacing parameters of 2.5V amplitude, 500 ohm impedance, 60 bpmpacing rate, 0.4 ms pulse-width. The foregoing pacing parameterscorrespond to a current draw of about 1.9 μA. The same LP 102 mayimplement an event message utilizing event signaling parameters foramplitude, pulse-width, pulse rate, etc. that correspond to a currentdraw of approximately 0.5 μA for transmit.

An LP 102 may combine the event message transmissions with pacingpulses. For example, an LP 102 may use a 50 μs wakeup transmit pulsehaving an amplitude of 2.5V which would draw 250 nC (nano Coulombs) foran electrode load of 500 ohm. The pulses of the transmit event messagemay be followed by an event message encoded with a sequence of shortduration pulses (for example 16, 2 μs on/off bits) which would draw anadditional 80 nC. The event message pulse would then be followed by theremaining pulse-width needed to reach an equivalent charge of a nominal0.4 ms pace pulse. In this case, the current necessary to transmit themarker is essentially free as it was used to achieve the necessary pacecapture anyhow. With this method, the savings in transmit current couldbe budgeted for the receiver or would allow for additional longevity.

When an LP 102 senses an intrinsic event, it can send a qualitativelysimilar event pulse sequence (but indicative of a sensed event) withoutadding the pace pulse remainder. Where longevity calculations for an LP102 are designed based on the assumption that the LP 102 will deliverpacing therapy 100% of the time, transmitting an intrinsic event markerto another LP 102 should not impact the nominal calculated LP longevity.

In some embodiments, the individual LP 102 can comprise a hermetichousing 110 configured for placement on or attachment to the inside oroutside of a cardiac chamber and at least two leadless electrodes 108proximal to the housing 110 and configured for bidirectionalcommunication with at least one other device 106 within or outside thebody. As will be described in additional detail below, with reference toFIGS. 5A and 5B, in certain embodiments an individual LP includes twohermetic housings, one of which includes electronic circuitry, and theother of which includes a battery.

Referring to FIG. 1B, the LP 102 is shown as including an accelerometer154 which can be hermetically contained within the housing 110. Theaccelerometer 154 can be any one of various different types ofwell-known accelerometers, or can be a future developed accelerometer.For one example, the accelerometer 154 can be or include, e.g., a MEMS(micro-electromechanical system) multi-axis accelerometer of the typeexploiting capacitive or optical cantilever beam techniques, or apiezoelectric accelerometer that employs the piezoelectric effect ofcertain materials to measure dynamic changes in mechanical variables.Where the accelerometer is a multi-axis accelerometer it can include twoor three sensors aligned along orthogonal axes. Exemplary multi-axisaccelerometers (also referred to as multi-dimensional accelerometers)that can be used are described in U.S. Pat. No. 6,658,292 (Kroll et al.)and U.S. Pat. No. 6,466,821 (Pianca et al.), each of which isincorporated herein by reference. For another example, a commerciallyavailable micro-electromechanical system (MEMS) accelerometer marketedas the ADXL345 by Analog Devices, Inc. (headquartered in Norwood, Mass.)is a three-axis accelerometer and includes polysilicon springs thatprovide a resistance against acceleration forces. The term MEMS has beendefined generally as a system or device having micro-circuitry on a tinysilicon chip into which some mechanical device such as a mirror or asensor has been manufactured. The aforementioned ADXL345 includes amicro-machined accelerometer co-packaged with a signal processing IC.

Another commercially available MEMS accelerometer is the ADXL327 byAnalog Devices, Inc., which is a small, thin, low power, complete threeaxis accelerometer with signal conditioned voltage outputs. In theADXL327, the mechanical sensor and signal conditioning IC are packagedtogether. A further commercially available MEMS accelerometer that canbe used is the LIS3DH three-axis accelerometer by STMicroelectronics(headquartered in Geneva, Switzerland). Additional and/or alternativetypes of accelerometers may also be used. For example, it is also withinthe scope of the present technology for the accelerometer 154 to be abeam-type of accelerometer, an example of which is described in U.S.Pat. No. 6,252,335 (Nilsson et al.), which is incorporated herein byreference.

The accelerometer 154 can be, e.g., a one-dimensional (1D) accelerometer(also known as a one-axis accelerometer), a two-dimensional (2D)accelerometer (also known as a two-axis accelerometer), or athree-dimensional (3D) accelerometer (also known as a three-axisaccelerometer). A 1D accelerometer measures acceleration along one axis,e.g., the z-axis. A 2D accelerometer measures acceleration along twoaxes that are orthogonal to one another, e.g., the z-axis, and the x- ory-axis. A 3D accelerometer measures acceleration along three axes thatare orthogonal to one another, e.g., the z-axis, the x-axis, and they-axis. Each measure of acceleration (i.e., rate of change of velocity)can actually be a measure of proper acceleration, which is the rate ofchange of velocity of a body in its own instantaneous rest frame. Forexample, an accelerometer at rest on the surface of the Earth willmeasure an acceleration due to Earth's gravity, straight upwards (bydefinition) of g≈9.81 m/s{circumflex over ( )}2.

Where an LP 102 includes an accelerometer within a housing of the LP orattached thereto, the accelerometer can be used to measure theacceleration of the LP along one or more axes, which measurement(s) canbe used to determine the orientation of the LP. Accordingly, because theoutput(s) of the accelerometer can be used to determine the orientationof the LP, it can be said that the output(s) of the accelerometer (e.g.,154) are indicative of an orientation of the LP 102. More specifically,in accordance with certain embodiments, the controller 112 of an LP 102receives one or more outputs output(s) of the accelerometer 154, whichis/are indicative of an orientation of the LP 102. In such embodiments,the controller 112 can determine, based on the output(s) received fromthe accelerometer 154, an actual orientation of the LP 102. Each outputof the accelerometer 154 can comprise a respective signal.

One or more signals produced and output by the accelerometer 154 may beanalyzed with respect to frequency content, energy, duration, amplitudeand/or other characteristics. Such signals may or may not be amplifiedand/or filtered prior to being analyzed. For example, filtering may beperformed using lowpass, highpass and/or bandpass filters. The signalsoutput by the accelerometer 154 can be analog signals, which can beanalyzed in the analog domain, or can be converted to digital signals(by an analog-to-digital converter) and analyzed in the digital domain.Alternatively, the signals output by the accelerometer 154 can alreadybe in the digital domain.

The one or more signals output by the accelerometer 154 can be analyzedby the controller 112 and/or other circuitry. In certain embodiments,the accelerometer 154 is packaged along with an integrated circuit (IC)that is designed to analyze the signal(s) it generates. In suchembodiments, one or more outputs of the packaged sensor/IC can be anindication of acceleration along one or more axes. In other embodiments,the accelerometer 154 can be packaged along with an IC that performssignal conditioning (e.g., amplification and/or filtering), performsanalog-to-digital conversions, and stores digital data (indicative ofthe sensor output) in memory (e.g., RAM, which may or may not be withinthe same package). In such embodiments, the controller 112 or othercircuitry can read the digital data from the memory and analyze thedigital data. Other variations are also possible, and within the scopeof embodiments of the present technology. In accordance with certainembodiments of the present technology, described in additional detailbelow, a sensor signal produced by the accelerometer 154 of an LPimplanted in or on a cardiac chamber can be used to detect mechanicalcardiac activity associated with another cardiac chamber.

The LP 102 is also shown as including a pressure sensor 156. Inaccordance with certain embodiments, at least one of the accelerometer154 of the pressure sensor 156, or some other sensor, such as apiezoelectric crystal, or a sensor including an acoustic diaphragm, canbe used to sense sounds emitted from the patient's heart (also referredto as heart sounds) to provide a phonocardiogram (also known as a heartsound signal). Heart sounds are the noises generated by the beatingheart and the resultant flow of blood, and are typically referred to asS1, S2, S3 and S4. Depending upon which heart sound is being detected,the LP1 can appropriately time its pacing therapy. The S1 heart sound,which is typically the loudest and most detectable of the heart sounds,is caused by the sudden block of reverse blood flow due to closure ofthe atrioventricular valves (mitral and tricuspid) at the beginning ofventricular contraction. Isovolumic relaxation (IR) occurs duringventricular diastole and is demarcated approximately by closure of theaortic valve and the second heart sound (S2) and approximately byopening of the mitral valve and the third heart sound (S3), which ismore prominent in children and those with abnormal ventricular functionwhen compared to normal adults. The onset of isovolumic relaxation timecommences with aortic valve closure, which can be identified by theaortic component (A2) of the second heart sound (S2). The third heartsound (S3) has been linked to flow between the left atrium and the leftventricle, more generally LV filling, and thought to be due tocardiohemic vibrations powered by rapid deceleration of transmitralblood flow. The fourth heart sound (S4) may be present in the late stageof diastole and associated with atrial contraction, or kick, where thefinal 20% of the atrial output is delivered to the ventricles.

FIG. 1B depicts a single LP 102 and shows the LP's functional elementssubstantially enclosed in a hermetic housing 110. The LP 102 has atleast two electrodes 108 located within, on, or near the housing 110,for delivering pacing pulses to and sensing electrical activity from themuscle of the cardiac chamber, and for bidirectional communication withat least one other device within or outside the body. Hermeticfeedthroughs 130, 131 conduct electrode signals through the housing 110.The housing 110 contains a primary battery 114 to supply power forpacing, sensing, and communication. The housing 110 also containscircuits 132 for sensing cardiac activity from the electrodes 108,receivers 120, 122 for receiving information from at least one otherdevice via the electrodes 108, and the pulse generator 116 forgenerating pacing pulses for delivery via the electrodes 108 and alsofor transmitting information to at least one other device via theelectrodes 108. The housing 110 can further contain circuits formonitoring device health, for example a battery current monitor 136 anda battery voltage monitor 138, and can contain circuits for controllingoperations in a predetermined manner.

In FIG. 1B, all of the components shown within the housing 110, besidesthe battery 114, can be referred generally as electrical circuitry orelectronics of the LP 102. In FIG. 1B the battery 114 and theelectronics are shown as being within the same housing 110. In certainembodiments of the present technology, described below with reference toFIGS. 5A and 5B, the battery 114 and the electronics are included withinseparate respective electrically conductive housings (e.g., 512 and 522in FIG. 5A) that are electrically isolated from one another.

The electrodes 108 can be configured to communicate bidirectionallyamong the multiple LPs and/or the implanted ICD 106 to coordinate pacingpulse delivery and optionally other therapeutic or diagnostic featuresusing messages that identify an event at an individual LP originatingthe message and an LP receiving the message react as directed by themessage depending on the origin of the message. An LP 102 that receivesthe event message reacts as directed by the event message depending onthe message origin or location. In some embodiments or conditions, thetwo or more leadless electrodes 108 can be configured to communicatebidirectionally among the one or more LPs 102 and/or the ICD 106 andtransmit data including designated codes for events detected or createdby an individual LP, Individual LPs can be configured to issue a uniquecode corresponding to an event type and a location of the sendingpacemaker. While the LP 102 shown in FIG. 1B is shown as including onlytwo electrodes 108, in alternative embodiments discussed below, an LPcan include more than two electrodes.

In some embodiments, an individual LP 102 can be configured to deliver apacing pulse with an event message encoded therein, with a code assignedaccording to pacemaker location and configured to transmit a message toone or more other LPs via the event message coded pacing pulse. Thepacemaker or pacemakers receiving the message are adapted to respond tothe message in a predetermined manner depending on type and location ofthe event.

Moreover, information communicated on the incoming channel can alsoinclude an event message from another leadless cardiac pacemakersignifying that the other leadless cardiac pacemaker has sensed aheartbeat or has delivered a pacing pulse, and identifies the locationof the other pacemaker. For example, LP 102 b may receive and relay anevent message from LP 102 a to the programmer. Similarly, informationcommunicated on the outgoing channel can also include a message toanother LP, or to the ICD, that the sending leadless cardiac pacemakerhas sensed a heartbeat or has delivered a pacing pulse at the locationof the sending pacemaker.

Referring again to FIG. 1A, the cardiac pacing system 100 may comprisean implantable cardioverter-defibrillator (ICD) 106 in addition to LPs102 configured for implantation in electrical contact with a cardiacchamber and for performing cardiac rhythm management functions incombination with the implantable ICD 106. The implantable ICD 106 andthe one or more LPs 102 can be configured for leadlessintercommunication by information conduction through body tissue and/orwireless transmission between transmitters and receivers in accordancewith the discussed herein.

As shown in the illustrative embodiments, an LP 102 can comprise two ormore leadless electrodes 108 configured for delivering cardiac pacingpulses, sensing evoked and/or natural (i.e., intrinsic) cardiacelectrical signals, and bidirectionally communicating with theco-implanted ICD 106.

LP 102 can be configured for operation in a particular location and aparticular functionality at manufacture and/or at programming by anexternal programmer 109. Bidirectional communication among the multipleleadless cardiac pacemakers can be arranged to communicate notificationof a sensed heartbeat or delivered pacing pulse event and encoding typeand location of the event to another implanted pacemaker or pacemakers.LP 102 receiving the communication decode the information and responddepending on location of the receiving pacemaker and predeterminedsystem functionality.

In some embodiments, the LPs 102 are configured to be implantable in anychamber of the heart, namely either atrium (RA, LA) or either ventricle(RV, LV). Furthermore, for multi-chamber configurations, multiple LPsmay be co-implanted (e.g., one in the RA, one in the RV, and one in theLV or in the coronary sinus proximate the LV). Certain pacemakerparameters and functions depend on (or assume) knowledge of the chamberin which the pacemaker is implanted (and thus with which the LP isinteracting; e.g., pacing and/or sensing). Some non-limiting examplesinclude: sensing sensitivity, an evoked response algorithm, use of AFsuppression in a local chamber, blanking and refractory periods, etc.Accordingly, each LP preferably knows an identity of the chamber inwhich the LP is implanted, and processes may be implemented toautomatically identify a local chamber associated with each LP.

Processes for chamber identification may also be applied to subcutaneouspacemakers, ICDs, with leads and the like. A device with one or moreimplanted leads, identification and/or confirmation of the chamber intowhich the lead was implanted could be useful in several pertinentscenarios. For example, for a DR or CRT device, automatic identificationand confirmation could mitigate against the possibility of the clinicianinadvertently placing the V lead into the A port of the implantablemedical device, and vice-versa. As another example, for an SR device,automatic identification of implanted chamber could enable the deviceand/or programmer to select and present the proper subset of pacingmodes (e.g., AAI or VVI), and for the IPG to utilize the proper set ofsettings and algorithms (e.g., V-AutoCapture vs. ACap-Confirm, sensingsensitivities, etc.).

Also shown in FIG. 1B, the primary battery 114 has positive pole 140 andnegative pole 142. Current from the positive pole 140 of primary battery114 flows through a shunt 144 to a regulator circuit 146 to create apositive voltage supply 148 suitable for powering the remainingcircuitry of the pacemaker 102. The shunt 144 enables the batterycurrent monitor 136 to provide the controller 112 with an indication ofbattery current drain and indirectly of device health. The illustrativepower supply can be a primary battery 114.

In various embodiments, LP 102 can manage power consumption to drawlimited power from the battery, thereby reducing device volume. Eachcircuit in the system can be designed to avoid large peak currents. Forexample, cardiac pacing can be achieved by discharging a tank capacitor(not shown) across the pacing electrodes. Recharging of the tankcapacitor is typically controlled by a charge pump circuit. In aparticular embodiment, the charge pump circuit is throttled to rechargethe tank capacitor at constant power from the battery.

In some embodiments, the controller 112 in one LP 102 can access signalson the electrodes 108 and can examine output pulse duration from anotherpacemaker for usage as a signature for determining triggeringinformation validity and, for a signature arriving within predeterminedlimits, activating delivery of a pacing pulse following a predetermineddelay of zero or more milliseconds. The predetermined delay can bepreset at manufacture, programmed via an external programmer, ordetermined by adaptive monitoring to facilitate recognition of thetriggering signal and discriminating the triggering signal from noise.In some embodiments or in some conditions, the controller 112 canexamine output pulse waveform from another leadless cardiac pacemakerfor usage as a signature for determining triggering information validityand, for a signature arriving within predetermined limits, activatingdelivery of a pacing pulse following a predetermined delay of zero ormore milliseconds.

In certain embodiments, the electrodes of an LP 102 can be used to sensean intracardiac electrocardiogram (IEGM) from which atrial and/orventricular activity can be detected, e.g., by detecting R waves and/orP waves. Accordingly, the sensed IEGM can be used by an LP to time itsdelivery of pacing pulses. Where an IEGM sensed by an LP is indicativeof electrical cardiac activity associated with the same cardiac chamberwithin or on which an LP is implanted, the IEGM can be referred to as anear-field signal. Where an IEGM sensed by an LP is indicative ofelectrical cardiac activity associate with another cardiac chamber ofthe heart (other than the cardiac chamber within or on which the LP isimplanted), the IEGM can be referred to as a far-field signal. An IEGMcan also be used by an LP 102 to time when i2i communication pulsesshould be generated and transmitted, since the orientation of the LPs102 relative to one another can change throughout each cardiac cycle.

FIG. 2 shows an LP 102. The LP can include a hermetic housing 202 (e.g.,the housing 110 in FIG. 1) with electrodes 108 a and 108 b disposedthereon. As shown, electrode 108 a can be separated from but surroundedpartially by a fixation mechanism 205, and the electrode 108 b can bedisposed on the housing 202. The fixation mechanism 205 can be afixation helix, a plurality of hooks, barbs, or other attaching featuresconfigured to attach the pacemaker to tissue, such as heart tissue. Theelectrodes 108 a and 108 b are examples of the electrodes 108 shown inand discussed above with reference to FIG. 1B. One of the electrodes 108(e.g., 108 a) can function as a cathode type electrode and another oneof the electrodes 108 (e.g., 108 b) can function as an anode typeelectrode, or vice versa, when the electrodes are used for deliveringstimulation. The electrode 108 a is an example of a tip electrode, andthe electrode 108 b is an example or a ring electrode. The electrodes108 a and 108 b can be referred to collectively as the electrodes 108,or individually as the electrode 108. While the LP 102 shown in FIG. 2is shown as including only two electrodes 108, in alternativeembodiments discussed below, an LP can include more than two electrodes.The LP 102 shown in FIG. 2 is also shown as including a retrievalfeature 207, which can include a “button” or circular grasping featurethat is configured to dock within a docking cap or a retrieval catheterthat can be used to remove the LP 102 when it needs to be removed and/orreplaced. Alternative form factors for the retrieval feature are alsopossible.

Where an LP includes more than two electrodes, a first subset of theelectrodes can be used for delivering pacing pulses, a second subset ofthe electrodes can be used for sensing a near-field signal, a thirdsubset of the electrodes can be used for sensing a far-field signal, anda fourth subset of the electrodes can be used for transmitting andreceiving i2i messages. One or more of the first, second, third, andforth subsets of electrodes can be the same, or they can all differ fromone another. As used herein, the term near-field signal refers to asignal that originates in a local chamber (i.e., the same chamber)within which or on which corresponding sense electrodes (and the LPincluding the sense electrodes) are located. Conversely, the termfar-field signal refers to a signal that originates in a chamber otherthan the local chamber within which or on which corresponding senseelectrodes (and the LP including the sense electrodes) are located.

The housing 202 can also include an electronics compartment 210 withinthe housing that contains the electronic components necessary foroperation of the pacemaker, including, e.g., a pulse generator,receiver, and a processor for operation. The hermetic housing 202 can beadapted to be implanted on or in a human heart, and can be cylindricallyshaped, rectangular, spherical, or any other appropriate shapes, forexample.

The housing 202 can comprise a conductive, biocompatible, inert, andanodically safe material such as titanium, 316L stainless steel, orother similar materials. The housing 202 can further comprise aninsulator disposed on the conductive material to separate electrodes 108a and 108 b. The insulator can be an insulative coating on a portion ofthe housing between the electrodes, and can comprise materials such assilicone, polyurethane, parylene, or another biocompatible electricalinsulator commonly used for implantable medical devices. In theembodiment of FIG. 2, a single insulator 208 is disposed along theportion of the housing between electrodes 108 a and 108 b. In someembodiments, the housing itself can comprise an insulator instead of aconductor, such as an alumina ceramic or other similar materials, andthe electrodes can be disposed upon the housing.

As shown in FIG. 2, the pacemaker can further include a header assembly212 to isolate electrodes 108 a and 108 b. The header assembly 212 canbe made from PEEK, tecothane or another biocompatible plastic, and cancontain a ceramic to metal feedthrough, a glass to metal feedthrough, orother appropriate feedthrough insulator as known in the art.

The electrodes 108 a and 108 b can comprise pace/sense electrodes, orreturn electrodes. A low-polarization coating can be applied to theelectrodes, such as sintered platinum, platinum-iridium, iridium,iridium-oxide, titanium-nitride, carbon, or other materials commonlyused to reduce polarization effects, for example. In FIG. 2, electrode108 a can be a pace/sense electrode and electrode 108 b can be a returnelectrode. The electrode 108 b can be a portion of the conductivehousing 202 that does not include an insulator 208. As noted above, anddescribed in additional detail below, an LP can include more than twoelectrodes, and may use different combinations of the electrodes forsensing a near-field signal, sensing a far-field signal, deliveringpacing pulses, and sending and receiving i2i messages. When theelectrode 108 a is used as a pace electrode it can also be referred toas the cathode.

Several techniques and structures can be used for attaching the housing202 to the interior or exterior wall of the heart. A helical fixationmechanism 205, can enable insertion of the device endocardially orepicardially through a guiding catheter. A torqueable catheter can beused to rotate the housing and force the fixation device into hearttissue, thus affixing the fixation device (and also the electrode 108 ain FIG. 2) into contact with stimulable tissue. Electrode 108 b canserve as an indifferent electrode (also referred to as the anode) forsensing and pacing. The fixation mechanism may be coated partially or infull for electrical insulation, and a steroid-eluting matrix may beincluded on or near the device to minimize fibrotic reaction, as isknown in conventional pacing electrode-leads.

Implant-to-Implant (i2i) Event Messaging

The LPs 102 can utilize implant-to-implant (i2i) communication throughevent messages to coordinate operation with one another in variousmanners. The terms i2i communication, i2i event messages, and i2i eventmarkers are used interchangeably herein to refer to event relatedmessages and IMD/IMD operation related messages transmitted from animplanted device and directed to another implanted device (althoughexternal devices, e.g., a programmer, may also receive i2i eventmessages). In certain embodiments, the LPs 102 operate as independentleadless pacers maintaining beat-to-beat multi-chamber functionality viaa “Master/Slave” operational configuration. For descriptive purposes,the right atrial LP 102 a can also be referred to as the “raLP”, theright ventricular LP 102 b can also be referred to as the “rvLP”, andthe left ventricular LP 102 c can also be referred to as the “lvLP”. Oneof the LPs 102 a, 102 b, and 102 c can be designated as the “master”device, with the remaining LPs being “slave” devices. The master device,which can also be referred to as the master LP, orchestrates most or alldecision-making and timing determinations (including, for example,rate-response changes). Since the master LP will perform more processingthan the slave LPs, it would be beneficial of the master LP included alarger battery than the slave LPs, so that the longevity of the masterLP is similar to the longevity of the slave LPs, Since the RV chamberhas the most area available for implantation of an LP, the LP 102 b thatcan be implanted in the LV chamber (i.e., the rvLP) is a good candidatefor being the master LP, and for much of the remaining discussion it isassume that the LP 102 b (i.e., the rvLP) is the master LP. However, inalternative embodiments, one of the other LPs, e.g., the LP 102 a or theLP 102 c the raLP or the lvLP) can be designated as the master. Inaccordance with certain embodiments, the LP 102 that is designated asthe master device (e.g. rvLP) may implement all or most multi-chamberdiagnostic and therapy determination algorithms.

In accordance with certain embodiments, methods are provided forcoordinating operation between three LPs configured to be implantedentirely within (or alternatively on) first, second, and third chambersof the heart, namely the RA chamber, the RV chamber, and the LV chamber.A method transmits an event marker through conductive communicationthrough electrodes located along a housing of the first LP, the eventmarker indicative of one of a local paced or sensed event. The methoddetects, over a sensing channel, the event marker at the second LPand/or the third LP. The method identifies the event marker at thesecond LP and/or the third LP based on a predetermined patternconfigured to indicate that an event of interest has occurred in aremote chamber. In response to the identifying operation, the methodinitiates a related action in the second LP and/or the third LP.Additionally, the third LP can be responsive to an event caused ordetected by the second LP.

FIG. 3 is a timing diagram 300 demonstrating one example of an i2icommunication for a paced event. The i2i communication may betransmitted, for example, from the LP 102 a to the LP 102 b and/or theLP 102 c. As shown in FIG. 3, in this embodiment, an i2i transmission302 is sent prior to delivery of a pace pulse 304 by the transmitting LP(e.g., LP 102). This enables the receiving LP (e.g., LP 102 b) toprepare for the remote delivery of the pace pulse. The i2i transmission302 includes an envelope 306 that may include one or more individualpulses. For example, in this embodiment, envelope 306 includes a lowfrequency pulse 308 followed by a high frequency pulse train 310. Lowfrequency pulse 308 lasts for a period MRS, and high frequency pulsetrain 310 lasts for a period T_(i2iHF). The end of low frequency pulse308 and the beginning of high frequency pulse train 310 are separated bya gap period, T_(i2iGap).

As shown in FIG. 3, the i2i transmission 302 lasts for a periodT_(i2iP), and pace pulse 304 lasts for a period T_(pace). The end of i2itransmission 302 and the beginning of pace pulse 304 are separated by adelay period, T_(delayP). The delay period may be, for example, betweenapproximately 0.0 and 10.0 milliseconds (ms), particularly betweenapproximately 0.1 ms and 2.0 ms, and more particularly approximately 1.0ms. The term approximately, as used herein, means +1-10% of a specifiedvalue.

FIG. 4 is a timing diagram 400 demonstrating one example of an i2icommunication for a sensed event. The i2i communication may betransmitted, for example, from the LP 102 a to the LP 102 b and/or theLP 102 c. As shown in FIG. 4, in this embodiment, the transmitting LP(e.g., LP 102 a) detects the sensed event when a sensed intrinsicactivation 402 crosses a sense threshold 404. A predetermined delayperiod, T_(delayS), after the detection, the transmitting LP transmitsan i2i transmission 406 that lasts a predetermined period This. Thedelay period may be, for example, between approximately 0.0 and 10.0milliseconds (ms), particularly between approximately 0.1 ms and 2.0 ms,and more particularly approximately 1.0 ms.

As with i2i transmission 302, i2i transmission 406 may include anenvelope that may include one or more individual pulses. For example,similar to envelope 306, the envelope of i2i transmission 406 mayinclude a low frequency pulse followed by a high frequency pulse train.

Optionally, wherein the first LP is located in or on the RA chamber, thesecond LP is located in or on the RV chamber, and the third LP islocated in or on the LV chamber, the first LP can produce an AS/AP eventmarker to indicate that an atrial sensed (AS) event or atrial paced (AP)event has occurred or will occur in the immediate future. For example,the AS and AP event markers may be transmitted following thecorresponding AS or AP event. Alternatively, the first LP may transmitthe AP event marker slightly prior to delivering an atrial pacing pulse.The second LP and/or the third LP can initiate an atrioventricular (AV)interval after receiving an AS or AP event marker from the first LP; andinitiate a post atrial ventricular blanking (PAVB) interval afterreceiving an AP event marker from the first LP.

Optionally, the LPs may operate in a “pure” master/slave relation, wherethe master LP delivers “command” markers in addition to or in place of“event” markers. A command marker can direct one or more slave LPs toperform an action such as to deliver a pacing pulse and the like. Forexample, when a slave LP is located in an atrium and a master LP islocated in a ventricle, in a pure master/slave relation, the slave LPdelivers an immediate pacing pulse to the atrium when receiving an APcommand marker from the master LP.

In accordance with some embodiments, communication and synchronizationbetween the raLP, rvLP, and lvLP is implemented via conductedcommunication of markers/commands in the event messages (per i2icommunication protocol). As explained above, conducted communicationrepresents event messages transmitted from the sensing/pacing electrodesat frequencies outside the RF or Wi-Fi frequency range. Alternatively,the event messages may be conveyed over communication channels operatingin the RF or Wi-Fi frequency range. The figures and correspondingdescription below illustrate non-limiting examples of markers that maybe transmitted in event messages. The figures and correspondingdescription below also include the description of the markers andexamples of results that occur in the LP that receives the eventmessage. Table 2 represents exemplary event markers sent from the raLPto the rvLP and/or lvLP, while Table 3 represents exemplary eventmarkers sent from the rvLP to the raLP and/or lvLP, or from the lvLP tothe raLP and/or rvLP. In the master/slave configuration, AS eventmarkers are sent from the aLP each time that an atrial event is sensedoutside of the post ventricular atrial blanking (PVAB) interval or someother alternatively-defined atrial blanking period. The AP event markersare sent from the raLP each time that the raLP delivers a pacing pulsein the atrium. The raLP may restrict transmission of AS markers, wherebythe raLP transmits AS event markers when atrial events are sensed bothoutside of the PVAB interval and outside the post ventricular atrialrefractory period (PVARP) or some other alternatively-defined atrialrefractory period. Alternatively, the raLP may not restrict transmissionof AS event markers based on the PVARP, but instead transmit the ASevent marker every time an atrial event is sensed.

TABLE 2 “A2V” Markers/Commands (e.g., from raLP to rvLP and/or lvLP)Marker Description Result in rvLP and/or lvLP AS Notification of asensed event Initiate AV interval (if not in in atrium (if not in PVABor PVAB or PVARP) PVARP) AP Notification of a paced event in InitiatePAVB atrium Initiate AV interval (if not in PVARP)

As shown in Table 2, when an raLP transmits an event message thatincludes an AS event marker (indicating that the raLP sensed anintrinsic atrial event), the rvLP and/or lvLP may initiate an AVinterval timer. If the raLP transmits an AS event marker for all sensedevents, then the rvLP and/or lvLP would preferably first determine thata PVAB or PVARP interval is not active before initiating an AV intervaltimer. If however the raLP transmits an AS event marker only when anintrinsic signal is sensed outside of a PVAB or PVARP interval, then thervLP and/or lvLP could initiate the AV interval timer upon receiving anAS event marker without first checking the PVAB or PVARP status. Whenthe raLP transmits an AP event marker (indicating that the raLPdelivered or is about to deliver a pace pulse to the atrium), the rvLPand/or lvLP can initiate a PVAB timer and an AV interval time, providedthat a PVARP interval is not active. The rvLP and/or lvLP may also blankits sense amplifiers to prevent possible crosstalk sensing of the remotepace pulse delivered by the raLP.

TABLE 3 “V2A” Markers/Commands (e.g., from rvLP, or lvLP, to raLP)Marker Description Result in raLP VS Notification of a sensed eventInitiate PVARP in ventricle VP Notification of a paced event in InitiatePVAB ventricle Initiate PVARP AP Command to deliver Deliver immediatepace immediate pace pulse in pulse to atrium atrium

As shown in Table 3, when the rvLP and/or lvLP senses a ventricularevent, it can transmit an event message including a VS event marker, inresponse to which the raLP may initiate a PVARP interval timer. When thervLP delivers or is about to deliver a pace pulse in the rightventricle, the rvLP transmits a VP event marker. When the raLP receivesthe VP event marker, the raLP can initiate a PVAB interval timer andalso a PVARP interval timer. The raLP may also blank its senseamplifiers to prevent possible crosstalk sensing of the remote pacepulse delivered by the rvLP. The rvLP may also transmit an event messagecontaining an AP command marker to command the raLP to deliver animmediate pacing pulse in the atrium upon receipt of the command withoutdelay.

The foregoing event markers are examples of a subset of markers that maybe used to enable the raLP, rvLP and lvLP to maintain full CRTfunctionality, In one embodiment, the master LP (e.g., the rvLP) mayperform all CRT algorithms, while the raLP may perform atrial-basedhardware-related functions, such as PVAB, implemented locally within theraLP. In this embodiment, the raLP is effectively treated as a remote‘wireless’ atrial pace/sense electrode. In another embodiment, themaster LP (e.g., the rvLP) may perform most but not all CRT algorithms,while the raLP may perform a subset of diagnostic and therapeuticalgorithms. In an alternative embodiment, rvLP, lvLP and raLP mayequally perform diagnostic and therapeutic algorithms. In certainembodiments, decision responsibilities may be partitioned separately toone of the raLP, rvLP or lvLP. In other embodiments, decisionresponsibilities may involve joint inputs and responsibilities.

In the event that LP to LP (i2i) communication is lost (prolonged ortransient), the system 100 may automatically revert to safeventricular-based pace/sense functionalities as the rvLP device isrunning all of the necessary algorithms to independently achieve thesefunctionalities. For example, if the rvLP loses i2i communication it mayrevert from the VDD mode to a VVI mode or a VDI mode, and if the raLPloses i2i communication it may revert from ADD mode to an OAO mode or anAAI mode. Thereafter, once i2i communication is restored, the system 100can automatically resume CRT functionalities.

As also noted above, a transmitter (e.g., 118) of an LP 102 may beconfigured to transmit event messages in a manner that does notinadvertently capture the heart in the chamber where LP 102 is located,such as when the associated chamber is not in a refractory state. Inaddition, an LP 102 that receives an event message may enter an “eventrefractory” state (or event blanking state) following receipt of theevent message. The event refractory/blanking state may be set to extendfor a determined period of time after receipt of an event message inorder to avoid the receiving LP 102 from inadvertently sensing anothersignal as an event message that might otherwise cause retriggering. Forexample, the receiving LP 102 may detect a measurement pulse fromanother LP 102. The amplitude of a detected (i.e., sensed) measurementpulse can be referred to as the sensed amplitude.

Referring back to FIG. 2, the LP 102 shown therein included just twoelectrodes, including the tip electrode 108 a and the ring electrode 108b. As noted above, one or more of the LPs 102 can include more than twoelectrodes. Examples of LPs 102 that include three electrodes aredescribed below with reference to FIGS. 5A and 5B.

Leadless Pacemaker (LP) Implementations

FIGS. 5A and 5B illustrate exemplary LPs that enables the LPs toeffectively deliver pacing pulses to the cardiac chamber within or onwhich the LP is implanted, effectively sense near-field signals, as wellas effectively sense far-field signals. A near-field signal can be usedby the LP that senses the near-field signal to monitor electricalcardiac activity of the cardiac chamber within or on which the LP isimplanted, which cardiac chamber can be referred to as the localchamber. A far-field signal can be used by the LP that senses thefar-field signal to monitor electrical cardiac activity associated withanother chamber of the heart (within or on which the LP that obtains thefar-field signal is not implanted). Such other cardiac chamber of theheart (within or on which an LP is not implanted) can also be referredto herein as a remote chamber. The LP can also perform i2icommunications.

Referring to FIG. 5A, an LP 102′, according to an embodiment of thepresent technology, is shown therein. The LP 102′ is shown as includingtwo separate housings 512 and 522, each of which is made of anelectrically conductive material. The housings 512 and 522 can be madeof the same type of electrically conductive material as one another, orof different types of electrically conductive materials than oneanother. The electrically conductive material of which the housing 512and/or the housing 522 is made can be an electrically conductivebiocompatible metal or alloy, such as stainless steel, a cobalt-chromiumalloy, titanium, or a titanium alloy, but is not limited thereto. Itwould also be possible for the electrically conductive material of whichthe housing 512 and/or the housing 522 is made to be a currentlydeveloped or future developed electrically conductive polymericmaterial. Since the housings 512 and 522 are each made of anelectrically conductive material, they can also be referred to aselectrically conductive housings 512 and 522.

As shown in FIG. 5A, electronic circuitry 514 (also referred to aselectronics) is included within the housing 512, and a battery 524(e.g., the battery 114 in FIG. 1B) is located within the housing 522.The electronic circuitry 512 can include, e.g., one or more pulsegenerators, one or more sense amplifiers, switches, a controller,memory, and/or the like. Such a controller can include one or moreprocessors, and/or an application-specific integrated circuit (ASIC),but is not limited thereto. Exemplary details of the electroniccircuitry 512 were discussed above with reference to FIG. 1B, and arealso discussed below with reference to FIG. 11. Since the electroniccircuitry 512 can likely be made smaller in size that the battery 524(which should preferably power the LP for a few years), it is likelythat the housing 522 which encases the battery 524 is larger in volumethan the housing 512 which encases the electronic circuitry 514. Thehousings 512 and 522 are preferably hermetic housings that protect theelectronic circuitry 514 and the battery 524 from the harsh environmentof the human body.

Still referring to FIG. 5A, an inter-housing insulator 532 is locatedbetween the housing 512 and the housing 522 to electrically isolate thehousings 512 and 514 from one another. The inter-housing insulator 532can be made, e.g., of sapphire, ruby, a biocompatible glass (e.g.,borosilicate glass) or a biocompatible ceramic, but is not limitedthereto. Exemplary biocompatible ceramics include, but is not limitedaluminum nitride (AlN), zirconia (ZrO2), silicon carbide (SiC), andsilicon nitride (Si3N4).

In certain embodiments each of the housings 512 and 522 has a generallycylindrical shape. As shown in FIG. 5A, each of the housings 512 and 522has an end that is connected to the inter-housing insulator 532, and anopposing end that can be referred to as the “free end” of the respectivehousing. The end of each housing 512 and 522 that is not the free endcan be referred to as the “non-free end”. The non-free end of thehousing 512 can be physically attached to a first side of theinter-housing insulator 532. Similarly, the non-free end of the housing522 can be physically attached to a second side of the inter-housinginsulator 532. Where each of the housings 512 and 522 has a generallycylindrical shape the inter-housing insulator may have an annular shapeor a disk-like shape, but is not limited thereto. For more specificexamples, the inter-housing insulator 532 can be an annular shapedceramic or glass collar.

Preferably there is a hermetic bonding between the non-free end of thehousing 512 and the first side of the inter-housing insulator 532, and ahermetic bonding between the non-free end of the housing 522 and thesecond side of the inter-housing insulator 532. For example, fusionwelding methods, such as laser welding, tungsten inert gas welding(TIG), or electron-beam welding can be used to hermetically bond ends ofeach of the first and second housings 512 and 522 to the first andsecond sides of the inter-housing insulator 532. In certain embodiments,multiple hermetic seals are provided between an end of a housing (512 or522) and a side of the inter-housing insulator. Such hermetic seals caninclude, e.g., one or more glass-to-tantalum seals produced by meltingglass with an infrared laser beam, and one or more hermetic sealsobtained by melting a tantalum tube closed in a plasma needle arcwelder, but are not limited thereto.

The battery 524 can be any one of various different types of batteries,such as, but not limited to, a lithium battery, e.g., a lithium carbonmonofluoride (Li—CFx) battery. The use of other types of batteries isalso possible and within the scope of the embodiments described herein.The battery 524 has a positive (+) pole and a negative (−) pole. Inaccordance with certain embodiments where the battery 524 is an Li—CFxbattery, lithium (Li) provides the anode or negative (−) pole of thebattery, and carbon monofluoride (CFx) provides the cathode or positive(+) pole of the battery. When referring to the battery 524, the positive(+) pole can also be referred to as the positive (+) terminal, and thenegative (−) pole can also be referred to as the negative (−) terminal.

In accordance with certain embodiments, the negative (−) pole of thebattery 524 is connected to the electrically conductive housing 522 thatencases the battery 524. The connection between the negative (−) pole ofthe battery 524 and the electrically conductive housing 522 can be via awire or other electrical conductor. Alternatively, the battery 524 canbe designed and manufactured such that the outer-casing of the battery524 is electrically connected to the negative (−) pole of the battery,or more generally, provides the negative (−) pole for the battery. Wherethe outer-casing of the battery 524 provides the negative (−) pole ofthe battery, then the negative (−) pole of the battery 524 will beconnected to the electrically conductive housing 522 so long as theouter-casing of the battery 524 is physically in contact with theelectrically conductive housing 522. Unless stated otherwise, it will beassumed that the outer-casing of the battery 524 provides the negative(−) pole of the battery. However, it should be noted that in alternativeembodiments the battery 524 can be designed and manufactured such thatthe outer-casing of the battery 524 is electrically connected to thepositive (+) pole of the battery, or more generally, provides thepositive (+) pole for the battery.

Conductors 534 and 536 that extend through the inter-housing insulator532 connect the positive (+) and negative (−) poles of the battery 524to the electronics 514, which are encased within the electricallyconductive housing 512, to thereby enable the battery 524 to providepower to the electronics 514.

The LP 102′ is shown as including a tip electrode 508 that is locatedadjacent to the free end of the housing 512. The tip electrode 508 iselectrically isolated from the electrically conductive housing 512 by aninsulator 506. A feedthrough 509 that extends through the insulator 506is used to connect the tip electrode 508 to the electronics 514 (e.g.,one or more pulse generators and/or one or more sense amplifiers). Thetip electrode 508 can have various different shapes, depending uponimplementation. For example, the tip electrode 508 can have an annularshape, a semi-spherical cap, or a helical shape to enable the tipelectrode 508 to also function as an attachment mechanism for attachingthe LP 102′ to an interior or exterior wall of a cardiac chamber. Wherethe tip electrode 508 has a helical shape it can also be referred to asa helical or helix electrode. Other shapes for the tip electrode 508 arealso possible and within the embodiments of the present technologydescribed herein.

The LP 102′ is also shown as including a ring electrode 518 and a ringelectrode 528. In certain embodiments, the ring electrode 518 isprovided by a non-insulated portion of the electrically conductivehousing 512. More specifically, portions of the electrically conductivehousing 512 can be coated or otherwise covered by an insulator 516, anda non-insulated portion of the housing 512 can provide the ringelectrode 518. Similarly, the ring electrode 528 can be provided by anon-insulated portion of the electrically conductive housing 522. Morespecifically, portions of the electrically conductive housing 522 can becoated or otherwise covered by an insulator 526, and a non-insulatedportion of the housing 522 can provide the ring electrode 528. Suchinsulators 516 and 526 can be made various different types ofbiocompatible insulating materials, such as, but not limited to,ceramic, polyurethane, parylene, or silicone.

Where the outer-casing of the battery 524 provides the negative (−) poleof the battery, and the outer-casing of the battery 524 is physically incontact with the electrically conductive housing 522, then theelectrically conductive housing 522 is electrically connected to thenegative (−) pole (aka the negative terminal) of the battery 524. Whenusing such a battery 524, an advantage of having the inter-housinginsulator 532 electrically isolate the housings 512 and 522 from oneanother is that a single common feedthrough (536 in FIG. 5A) can be usedto connect the electronics 514 to the negative (−) pole of the battery524 and the ring electrode 528. A further advantage of having theinter-housing insulator 532 electrically isolate the housings 512 and522 from one another is that a non-insulated portion of each of thehousings can be used to provide respective ring electrodes 518 and 528.Another advantage of having the inter-housing insulator 532 electricallyisolate the housings 512 and 522 from one another is that the ringelectrodes 518 and 528 can be used independently of one another.Further, it is noted that designing an LP to include three electrodesshould enable better sensing of far-field signals, compared to if the LPincluded only two electrodes.

In accordance with certain embodiments, during pacing of a cardiacchamber (e.g., RA chamber, RV chamber, or LV chamber) within or on whichthe LP 102′ is implanted, the tip electrode 508 is connected as thecathode and one of the ring electrodes 518 or 528 is connected as theanode. In other words, a tip-to-ring pacing vector can be used forpacing. It would also be possible that when performing pacing using thetip electrode 508 as the cathode, both ring electrodes 518 and 528 canbe connected as the anode (e.g., a distributed anode) at the same time.In accordance with certain embodiments, sensing can be performed usingone or more pair of the electrodes 508, 518, and 528. Additionally, i2icommunication can be performed using a pair of the electrodes 508, 518,and 528.

In an embodiment, if the LP 102′ is implanted within the RV chamber,then near-field sensing (of electrical cardiac activity associated withthe RV chamber) can be performed using the tip electrode 508 and thering electrode 518. In other words, a tip-to-ring sensing vector can beused for near-field sensing. In an embodiment, if the LP 102′ isimplanted in the RV chamber, then far-field sensing (of electricalcardiac activity associated with the RA chamber) can be performed usingthe tip electrode 508 and the ring electrode 528, since the ringelectrode 528 will be the electrode closest to the RA chamber. In otherwords, a separate tip-to-ring sensing vector can be used for far-fieldsensing than is used for near-field sensing. In still anotherembodiment, if the LP 102′ is implanted in the RV chamber, far-fieldsensing (of electrical cardiac activity associated with the RA chamber)can be performed using the ring electrode 518 and the ring electrode528. In other words, a ring-to-ring sensing vector can be used forfar-field sensing. The tip electrode 508 and the ring electrode 528 canbe used for i2i communication (both transmitting of i2i pulses andreceiving of i2i pulses) with another LP, another ND, and/or with anexternal device (e.g., programmer). Alternatively, the tip electrode 508and the ring electrode 518 can be used for i2i communication (bothtransmitting of i2i pulses and receiving of i2i pulses) with another LP,another IMD, and/or with an external device. In still other embodiments,the ring electrode 518 and the ring electrode 528 can be used for i2icommunication (both transmitting of i2i pulses and receiving of i2ipulses) with another LP, another IMD, and/or with an external device.

In an embodiment, if the LP 102′ is implanted within the RA chamber,then near-field sensing (of electrical cardiac activity associated withthe RA chamber) can be performed using the tip electrode 508 and thering electrode 518 (i.e., a tip-to-ring sensing vector can be used fornear-field sensing); far-field sensing (of electrical cardiac activityassociated with the RV chamber) can be performed using the tip electrode508 and the ring electrode 528 (since the ring electrode 528 will be theelectrode closest to the RV chamber) or using the ring electrode 518 andthe ring electrode 528; and the tip electrode 508 and one of the ringelectrodes 518 or 528 can be used for i2i communication (bothtransmitting of i2i pulses and receiving of i2i pulses) with another LP,another IMD, and/or with an external device, or the two ring electrode518 and 528 can be used for i2i communication.

More generally, when the LP 102′ is implanted within a cardiac chamber,near-field sensing (of electrical cardiac activity associated with thelocal chamber within which the LP 102′ is implanted) can be performedusing the tip electrode 508 and the ring electrode 518 (i.e., atip-to-ring sensing vector can be used for near-field sensing);far-field sensing (of electrical cardiac activity associated with aremote chamber) can be performed using the tip electrode 508 and thering electrode 528, or using the ring electrode 518 and the ringelectrode 528; and i2i communication can be performed using the tipelectrode 508 and one of the ring electrodes 518 or 528, or using bothring electrode 518 and 528. Other variations are also possible andwithin the scope of the embodiments of the present technology.

Still referring to FIG. 5A, the LP 102′ is also shown as including aretrieval feature 542, which can include a “button” or circular graspingfeature that is configured to dock within a docking cap or a retrievalcatheter that can be used to remove the LP 102′ when it needs to beremoved and/or replaced. Alternative form factors for the retrievalfeature are also possible. The retrieval feature 542 can be made of anon-electrically conductive material, i.e., an insulating material.Alternatively, the retrieval feature 542 can be made of an electricallyconductive material, and in the embodiment of FIG. 5A, can be coated orotherwise covered by a biocompatible insulating materials, such as, butnot limited to, ceramic, polyurethane, parylene, or silicone.

FIG. 56 is an illustration of a leadless pacemaker (LP) 102″ accordingto another embodiment of the present technology. Elements in FIG. 5Bthat are the same or similar to elements in FIG. 5A are numbered thesame and need not be described again in the same amount of detail. Inaccordance with certain embodiments, the retrieval feature 542 (or atleast a portion thereof) is made of an electrically conductive materialand is electrically connected to the negative (−) pole of the battery524. This enables the retrieval feature 542 (or at least a portionthereof) to be another tip electrode 548. Accordingly, the LP 102″includes the tip electrode 508 adjacent to the free end of the housing512, as well as a tip electrode adjacent to the free end of the housing522. Where the retrieval feature 542 provides a tip electrode 548, itcan also be referred to as the tip electrode 542/548. A comparisonbetween FIGS. 5A and 5B shows that a distinction of the LP 102″ is thatinstead of having one tip electrode and two ring electrodes, as was thecase with the LP 102′, the LP 102″ has two tip electrodes and one ringelectrode. It would also be possible that a portion of the free end ofthe housing 522 is not coated or otherwise covered with an insulatedmaterial to thereby provide a tip electrode adjacent to the free end ofthe housing 522. This would also provide the LP 102″ with two tipelectrodes and one ring electrode.

In accordance with certain embodiments, during pacing of a cardiacchamber (e.g., RA chamber, RV chamber, or LV chamber) within or on whichthe LP 102″ is implanted, the tip electrode 508 is connected as thecathode and the ring electrodes 518 is connected as the anode. In otherwords, a tip-to-ring pacing vector can be used for pacing. In accordancewith certain embodiments, sensing can be performed using one or morepair of the electrodes 502, 518, and 548. Additionally, i2icommunication can be performed using a pair of the electrodes 502, 518,and 548.

In an embodiment, if the LP 102″ is implanted within the RV chamber,then near-field sensing (of electrical cardiac activity associated withthe RV chamber) can be performed using the tip electrode 508 and thering electrode 518. In other words, a tip-to-ring sensing vector can beused for near-field sensing. In an embodiment, if the LP 102″ isimplanted in the RV chamber, then far-field sensing (e.g., of electricalcardiac activity associated with the RA chamber) can be performed usingthe tip electrode 508 and the tip electrode 548, since the tip electrode548 will be the electrode closest to the RA chamber. In other words, atip-to-tip sensing vector can be used for far-field sensing. In stillanother embodiment, if the LP 102″ is implanted in the RV chamber,far-field sensing (e.g., of electrical cardiac activity associated withthe RA chamber) can be performed using the ring electrode 518 and thetip electrode 548. In other words, a ring-to-tip sensing vector can beused for far-field sensing. The tip electrode 508 and the tip electrode548 can be used for i2i communication (both transmitting of i2i pulsesand receiving of i2i pulses) with another LP, another IMD, and/or forimplant to programmer (i2p) communication with an external device.Alternatively, the ring electrode 518 and the tip electrode 548 can beused for i2i communication (both transmitting of i2i pulses andreceiving of i2i pulses) with another LP, another IMD, and/or for i2pcommunication with an external device.

In an embodiment, if the LP 102″ is implanted within the RA chamber,then near-field sensing (e.g., of electrical cardiac activity associatedwith the RA chamber) can be performed using the tip electrode 508 andthe ring electrode 518 a tip-to-ring sensing vector can be used fornear-field sensing); far-field sensing (e.g., of electrical cardiacactivity associated with the RV chamber) can be performed using the tipelectrode 508 and the tip electrode 548 (since the tip electrode 548will be the electrode closest to the RV chamber) or using the ringelectrode 518 and the tip electrode 548. The tip electrode 508 and thetip electrode 548, or the ring electrode 518 and the tip electrode 548,can be used for i2i communication (both transmitting of i2i pulses andreceiving of i2i pulses) with another LP, another IMD, and/or for i2pcommunication with an external device.

More generally, when the LP 102″ is implanted within a cardiac chamber,near-field sensing (of electrical cardiac activity associated with thelocal chamber within which the LP 102″ is implanted) can be performedusing the tip electrode 508 and the ring electrode 518 (i.e., atip-to-ring sensing vector can be used for near-field sensing);far-field sensing (of electrical cardiac activity associated with aremote chamber) can be performed using the tip electrode 508 and the tipelectrode 548, or using the ring electrode 518 and the tip electrode548; and i2i communication can be performed using the tip electrode 508and the tip electrode 548, or using the ring electrode 518 and the tipelectrode 548. Other variations are also possible and within the scopeof the embodiments of the present technology.

Referring briefly back to FIG. 1B, only one sense amplifier 132 wasshown within the LP illustrated therein. In accordance with certainembodiments, an LP (e.g., 102, 102′ or 102″) includes multiple senseamplifier, e.g., one or more for sensing near-field signals, one or morefor sensing far-field signals, and one or more for sensing i2i signals.In FIG. 1B only one pulse generator 116 was shown within the LPillustrated therein. In accordance with certain embodiments, an LP(e.g., 102, 102′ or 102″) includes multiple pulse generators, e.g., onefor generating pacing signals, and one or more for generating i2isignals. Further, it should be noted that where an LP (e.g., 102, 102′or 102″) includes three or more electrodes, switch circuitry can belocated between the electrodes and the sense amplifier(s) and pulsegenerator(s), to enable a controller to control which electrodes areused to sense a near-field signal, which electrodes are used to sense afar-field signal, which electrodes are used for pacing, and to controlwhich electrodes are used for i2i communications.

Use of Far-Field and/or Sensor Signals to Supplement or Replace i2iMessaging

In accordance with certain embodiments of the present technology, one ormore accelerometers of an LP can be used to determine when the LP islikely in a deaf zone, and during such periods the LP can rely onfar-field sensing to time delivery of pacing within the chamber in whichthe LP is implanted. For example, the raLP can sense a far-field signalfrom which electrical cardiac activity associated with the RV chambercan be detected, and the raLP can perform ADD pacing by timing deliveryof atrial pulses based on the timing of cardiac activity associated withthe RV chamber as detected from the far-field signal. For anotherexample, the rvLP can sense a far-field signal from which electricalcardiac activity associated with the RA chamber can be detected, and thervLP can perform VDD pacing by timing delivery of ventricular pulsesbased on the timing of cardiac activity associated with the RA chamberas detected from the far-field signal. When an raLP implanted in the RAchamber times delivery of atrial pacing pulses based on the timing of RVcardiac activity as detected from a far-field signal sensed by the raLP,it can be said that the raLP times its delivery of atrial pacing pulsesbased on timing of RV cardiac activity detected by the raLP itself.Similarly, when an rvLP implanted in the RV chamber times delivery ofventricular pacing pulses based on the timing of RA cardiac activity asdetected from a far-field signal sensed by the rvLP, it can be said thatthe rvLP times its delivery of ventricular pacing pulses based on timingof RA cardiac activity as detected by the rvLP itself.

Depending upon the specific implementation, an raLP can primarily or bydefault time delivery of RA pacing pulses based on the timing of cardiacactivity associated with the RV chamber as determined based on i2imessages received by the raLP from a rvLP, and the raLP can, as abackup, time delivery of RA pacing pulses based on the timing of cardiacactivity associated with the RV chamber that the raLP detected itselffrom a far-field signal that the aLP sensed. Similarly, a rvLP canprimarily or by default time delivery of RV pacing pulses based on thetiming of cardiac activity associated with the RA chamber as determinedbased on i2i messages received by the rvLP from an raLP, and the rvLPcan, as a backup, time delivery of RV pacing pulses based on the timingof cardiac activity associated with the RA chamber that the rvLPdetected itself from a far-field signal that the rvLP sensed.

Alternatively, an raLP can primarily or by default time delivery of RApacing pulses based on the timing of cardiac activity associated withthe RV chamber as determined based on a far-field signal that the raLPsensed itself, and the raLP can, as a backup, time delivery of RA pacingpulses based on the timing of cardiac activity associated with the RVchamber as determined based on i2i messages received by the raLP from arvLP. Similarly, a rvLP can primarily or by default time delivery of RVpacing pulses based on the timing of cardiac activity associated withthe RA chamber as determined based on a far-field signal that the rvLPsensed itself, and the rvLP can, as a backup, time delivery of RV pacingpulses based on the timing of cardiac activity associated with the RAchamber as determined based on i2i messages received by the rvLP from anraLP.

In accordance with certain embodiments of the present technology,instead of (or in addition to) an LP detecting electrical cardiacactivity associated with another chamber based on a far-field signalsensed by the LP itself, the LP can use a sensor (e.g., an accelerometeror pressure sensor) to produce a sensor signal from which mechanicalcardiac activity associated with another chamber of the heart may bedetected. For example, the raLP can use an accelerometer or pressuresensor to produce a sensor signal from which heart sounds associatedwith the RV chamber can be detected, and the raLP can perform ADD pacingby timing delivery of atrial pulses based on the timing of cardiacactivity associated with the RV chamber as detected from the sensorsignal. For another example, the rvLP can use an accelerometer orpressure sensor to produce a sensor signal from which mechanical cardiacactivity associated with the RA chamber can be detected, and the rvLPcan perform VDD pacing by timing delivery of ventricular pulses based onthe timing of cardiac activity associated with the RA chamber asdetected from the sensor signal.

Where the rvLP performs VDD pacing, it performs ventricular pacing,atrial and ventricular (i.e., dual) sensing, dual (i.e., triggered andinhibited) response to a sensed event. VDD may be used, e.g., for AVnodal dysfunction but intact and appropriate sinus node behavior. Theventricular sensing can be based on a near-field signal that the rvLPsenses itself using a pair of its electrodes. Similarly, if the rvLPperforms VVI or VDI pacing, it can perform ventricular sensing based ona near-field signal that the rvLP senses itself using a pair of itselectrodes. Atrial sensing can be based on a Mr-field signal that thervLP senses itself using a pair of its electrodes, based on a sensorsignal that rvLP senses itself (e.g., using an accelerometer or pressuresensor of the rvLP), and/or based on i2i messages that the vLP receivesfrom the aLP.

Where the raLP performed ADD pacing, it performs atrial pacing, atrialand ventricular (i.e., dual) sensing, dual (i.e., triggered andinhibited) response to a sensed event. The atrial sensing can be basedon a near-field signal that the raLP senses itself using a pair of itselectrodes. Similarly, if the raLP performs AAI or ADI pacing, it canperform atrial sensing based on a near-field signal that the raLP sensesitself using a pair of its electrodes. Ventricular sensing can be basedon a far-field signal that the raLP senses itself using a pair of itselectrodes, based on a sensor signal that raLP senses itself (e.g.,using an accelerometer or pressure sensor of the raLP), and/or based oni2i messages that the raLP receives from the rvLP.

Any LP, of the raLP, the rvLP, and the lvLP, can deliver its pacingpulses based on timing it determines itself, e.g., from a far-fieldsignal or a sensor signal the LP senses itself, or it can deliver itspacing pulses based on timing determined from i2i signals received bythe LP from one or more other LPs. Far-field sensing that is performedby the raLP (e.g., 102 a) is of electrical activity in the ventricles.Far-field sensing that is performed by the rvLP (e.g., 102 b) is ofelectrical activity in the atrium and/or LV. Far-field sensing that isperformed by the lvLP (e.g., 102 c) is of electrical activity in theatrium and/or RV.

Cardiac Resynchronization Therapy (CRT)

The high level flow diagram of FIG. 6 will now be used to describecertain embodiments of the present technology for performing cardiacresynchronization therapy (CRT) using an implantable leadless pacemakersystem including an LP implanted in or on the RA chamber, an LPimplanted in or on the RV chamber, and an LP implanted in or on the LVchamber, wherein one of the LPs is designated a master LP. As notedabove, the LP implanted in or on the RA chamber can also be referred toas the raLP, the LP implanted in or on the RV chamber can also bereferred to as the rvLP, and the LP implanted in or on the LV chambercan also be referred to as the lvLP. Referring briefly back to FIG. 1A,the LP 102 a is an example of the raLP, the LP 102 b is an example ofthe rvLP, and the LP 102 c is an example of the lvLP. FIGS. 1B and 2illustrate exemplary implementation details of the LPs 102, according tocertain embodiments of the present technology. The LPs can instead beimplemented in accordance with the embodiments described with referenceto FIG. 5A or 5B, but are not limited thereto.

As noted above, one of the raLP, rvLP, and lvLP is designated the masterLP. The other two LPs, which are not designated the master LP, areconsidered slave LPs. Since the master LP will perform more processingthan the slave LPs, it would be beneficial of the master LP included alarger battery than the slave LPs, so that the longevity of the masterLP is similar to the longevity of the slave LPs, as was also notedabove. Since the RV chamber has the most area available for implantationof an LP, the rvLP is a good candidate for being the master LP, and forthe discussion of the flow diagram in FIG. 6 it will be assumed that thervLP is the master LP. However, in alternative embodiments, the raLP orthe lvLP can instead be designated as the master. The steps describedwith reference to FIGS. 6-10 can be performed solely by the LPs underthe supervision of the LP that is designed the master LP. Alternatively,an external programmer that wirelessly communications with the LPs cansupervise and/or assist with at least some of the steps.

Referring to FIG. 6, step 602 involves the master LP (e.g., the rvLP)determining an AV delay (to use for CRT) based on a P-wave duration.Additionally details of step 602, according to an embodiment of thetechnology, are described below with reference to FIGS. 7A, 7B and 7C,which can be collectively referred to as FIG. 7.

Still referring to FIG. 6, step 604 involves the master LP (e.g., thervLP) determining a value for a variable “delta” (Δ) that is for use indetermining a VV delay (to use for CRT). The variable “delta” (Δ)represents an interventricular delay that is based an atrio-ventriculardelay for the LV chamber and an atrio-ventricular delay for the RVchamber. Additionally details of step 604, according to an embodiment ofthe technology, are described below with reference to FIG. 8.

Still referring to FIG. 6, step 606 involves the master LP (e.g., thervLP) determining a value for a variable epsilon (ε) (also known as a“correction factor”) that is also for use in determining the VV delay(to use for CRT). Additionally details of step 606, according to anembodiment of the technology, are described below with reference to FIG.9.

Still referring to FIG. 6, step 608 involves the master LP (e.g., thervLP) determining the VV delay (to use for CRT) based on the determinedvalues for the delta (Δ) and the correction factor (ε), that weredetermined at steps 604 and 606, respectively. In accordance withspecific embodiments, the equation used to determine the VV delay atstep 608 is as follows:

VV delay=0.5*(Δ+ε).

Finally, at step 610, the master LP (e.g., the rvLP) orchestrates DODpacing, to perform CRT, using the AV delay and the VV delay, determinedat steps 602 and 608, respectively. Additional details of step 610,according to certain embodiments of the present technology, aredescribed below, following the discussion of FIGS. 7-9, e.g., withreference to FIG. 10.

Additional details of steps 602, 604, and 606, according to certainembodiments of the present technology, will now be described withreference to FIGS. 7, 8, and 9, respectively. In FIGS. 7A, 8, and 9, thesteps shown along the left side of a page are steps that are performedby the raLP (e.g., the LP 102 a in FIG. 1); the steps that are shown inthe middle of a page are steps that are performed by the rvLP (e.g., theLP 102 b in FIG. 1); and the steps that are shown along the right sideof a page, if any, are performed by the lvLP (e.g., the LP 102 c in FIG.1).

Referring to FIG. 7A, which provides additional details for step 602according to certain embodiments, step 702 involves the raLP (e.g., LP102 a) sensing or pacing an atrial event (i.e., an atrialdepolarization). Step 704 involves the raLP determining a P-waveduration from a sensed signal (i.e., an electrogram) indicative ofcardiac electrical activity in the atrium. The P-wave duration can bedetermined from a single cardiac cycle, i.e., from a single P-wave.Alternatively, and more preferably, the P-wave duration can bedetermined from a plurality of cardiac cycles, i.e., from a plurality ofP-waves, e.g., by determining the mean or median of the plurality ofP-waves.

Step 706 involves the raLP transmitting an i2i message to the master LP(e.g., the rvLP), wherein the i2i message includes the P-wave durationdetermined by the raLP. Step 722 involves the master LP (e.g., the rvLP)receiving the i2i message (from the raLP) that includes the P-waveduration. Step 724 involves the master LP (e.g., the rvLP) determiningan AV delay based on the determined P-wave duration. FIGS. 7B and 7Cprovide additional details of how step 724 can be performed, and morespecifically, how the AV delay can be determined based on the determinedP-wave duration. The specific AV delay to use for CRT pacing will dependon whether the AV delay is for use in pacing during one or more cardiaccycles that start with an intrinsic atrial event, or the AV delay is forusing in pacing during one or more cardiac cycles that start with apaced atrial event. Since it is unlikely to, be known beforehand whethera cardiac cycle will begin with an intrinsic or paced event, two typesof AV delays can be determined at step 724, one AV delay for use whenpacing during cardiac cycles that start with an intrinsic atrial event,and another AV delay for use when pacing during cardiac cycles thatstart with a paced atrial event. More specifically, the flow diagram inFIG. 7B illustrates how the AV delay can be determined when pacingstarts with an intrinsic atrial event, and the flow diagram of FIG. 7Cillustrates how the AV delay can be determined when pacing starts with apaced atrial event.

Referring to FIG. 7B, which illustrates how the AV delay can bedetermined when pacing starts with an intrinsic atrial event, at step732 the P-wave duration is compared to a first threshold, and at step734 there is a determination of whether the P-wave duration is greaterthan the first threshold. While shown as two separate steps, steps 732and 734 can be combined into a single step. An example value for thefirst threshold is 100 ms, but the use of alternatively values for thefirst threshold are also possible and within the scope of theembodiments described herein. If the answer to the determination at step734 is Yes (i.e., if the P-wave duration is greater than the firstthreshold), then at step 736 the AV delay is set to be equal to a sum ofthe P-wave duration plus a first offset (i.e., AV delay=P-waveduration+Offset₁). An example value for the first offset is 30 ms, butthe use of alternatively values for the first offset are also possibleand within the scope of the embodiments described herein. If the answerto the determination at step 734 is No (i.e., if the P-wave duration isnot greater than the first threshold), then at step 738 the AV delay isset to be equal to a sum of the P-wave duration plus a second offsetthat is greater than the first offset (i.e., AV delay=P-waveduration+Offset₂). An example value for the second offset is 60 ms, butthe use of alternatively values for the second offset are also possibleand within the scope of the embodiments described herein.

Referring to FIG. 7C, which illustrates how the AV delay can bedetermined when pacing starts with a paced atrial event, at step 742 theP-wave duration is compared to a second threshold, which is greater thanthe first threshold, and at step 744 there is a determination of whetherthe P-wave duration is greater than the second threshold. The reason thesecond threshold is greater than the first threshold is because ARintervals are greater than PR intervals due to there being some delaybetween delivery of a pacing pulse and capture of the atrial chamber.While shown as two separate steps, steps 742 and 744 can be combinedinto a single step. An example value for the second threshold is 150 ms,but the use of alternatively values for the second threshold are alsopossible and within the scope of the embodiments described herein. Ifthe answer to the determination at step 744 is Yes (i.e., if the P-waveduration is greater than the second threshold), then at step 736 the AVdelay is set to be equal to a sum of the P-wave duration plus a thirdoffset (i.e., AV delay=P-wave duration+Offset₃). An example value forthe third offset is 30 ms, but the use of alternatively values for thethird offset are also possible and within the scope of the embodimentsdescribed herein. If the answer to the determination at step 744 is No(i.e., if the P-wave duration is not greater than the second threshold),then at step 748 the AV delay is set to be equal to a sum of the P-waveduration plus a fourth offset that is greater than the third offset(i.e., AV delay=P-wave duration+Offset₄). An example value for thefourth offset is 60 ms, but the use of alternatively values for thefourth offset are also possible and within the scope of the embodimentsdescribed herein.

While it is preferable that the master LP performs a majority of thecalculations and other determinations, such as determining the AV delay,it would also be possible for the raLP to determine the AV delay basedon the P-wave duration, and then transmit the determined AV delay to themaster LP in an i2i message. It is also noted that if the raLP isdesignated the master LP (e.g., rather than the rvLP being designatedthe master LP), then steps 706 and 722 would not be needed, and the raLPcould both determine the P-wave duration and determine the AV delaybased on the P-wave duration. It is also within the scope of theembodiments described herein to use some other measure of inter-atrialconduction delay (IACD), besides P-wave duration, to determine the AVdelay.

FIG. 8 will now be used to describe additionally details of how the“delta” is determined at step 604, according to certain embodiments ofthe present technology. As noted above, the variable “delta” (Δ)represents an interventricular delay that is based an atrio-ventriculardelay for the LV chamber and an atrio-ventricular delay for the RVchamber. Referring to FIG. 8, step 802 involves the raLP (e.g., LP 102a) sensing or pacing an atrial event (i.e., an atrial depolarization),and step 804 involves the raLP transmitting an i2i indicative of thesensed or paced atrial event. Where an atrial event (i.e., an atrialdepolarization) is sensed at step 802, a time at which the atrial eventis considered to occur can be, e.g., at a beginning, a peak, or an endof a P-wave, so long as the way step 802 is performed is consistent. Thetransmitted i2i message can be detected by the rvLP, as indicated atstep 822, as well as by the lvLP, as indicated at step 842.

At step 824 the rvLP (e.g., 102 b) senses a ventricular event in the RVchamber that follows that atrial event that is sensed or paced in the RAchamber at step 802, and at step 826 a right ventricular (rv) PRinterval is determined (if the atrial event at step 802 was a sensedevent), or a rv AR interval is determined (if the atrial event at step802 was a paced event). Preferably, at steps 824 and 826, a time atwhich the ventricular event is considered to occur in the RV chamber isat a peak of an R-wave or QRS complex of an EGM indicative of electricalactivity in the RV chamber.

At step 844 the lvLP (e.g., 102 c) senses a ventricular event in the LVchamber that follows that atrial event that is sensed or paced in the RAchamber at step 802. For this discussion, it is presumed that the rvLP(e.g., 102 b) is designated the master LP, in which case the lvLP (e.g.,102 c), which is a slave, will transmit an i2i message indicative of theventricular event sensed in the LV chamber following the atrial eventsensed (or paced) in the RA chamber at step 802.

As indicated at step 828, the rvLP (e.g., 102 b) receives the i2imessage that was sent at step 846, and the rvLP at step 830 determines aleft ventricular (lv) PR interval (if the atrial event at step 802 was asensed event), or a lv AR interval (if the atrial event at step 802 wasa paced event). Preferably, at steps 844 and 830, a time at which theventricular event is considered to occur in the LV chamber is at a peakof an R-wave or QRS complex of an EGM indicative of electrical activityin the LV chamber.

At step 832, the master LP calculates the “delta” using the followingequation:

Δ=(lv AR or PR interval)−(rv AR or PR interval).

In other words, the “delta” is equal to the difference between the lv ARinterval and the rv AR interval, or is equal to the difference betweenthe lv PR interval and the rv PR interval. The flow diagram shown inFIG. 8 would be slightly changed if a different one of the LPs, otherthan the rvLP, was designated the master LP. As noted above, in thediscussion of step 608 of FIG. 6, the master LP determines the VV delaybased on as the “delta” (Δ), as well as the “correction factor” epsilon(ε).

FIG. 9 will now be used to describe additionally details of how the“correction factor” is determined at step 606, according to certainembodiments of the present technology. Referring to FIG. 9, step 902involves the raLP (e.g., LP 102 a) sensing or pacing an atrial event(i.e., an atrial depolarization), and step 904 involves the raLPtransmitting an i2i indicative of the sensed or paced atrial event. Thetransmitted i2i message can be detected by the rvLP, as indicated atstep 922, as well as by the lvLP, as indicated at step 942.

At step 924 the rvLP (e.g., LP 102 b) paces the RV chamber using arelatively short (e.g., 50 ms) AV delay, and the rvLP transmits an i2imessage indicative of the RV pace being delivered. For example, such ani2i message can include a VP maker that provides a notification of apaced ventricular event.

At step 944 the i2i message (transmitted at step 926) is received by thelvLP (e.g., LP 102 c), and at step 946 the lvLP senses an LV event(i.e., left ventricular depolarization) that is responsive to the RVpace. At step 948 the lvLP transmits an i2i message indicative of the LVevent detected at step 946. For example, such an i2i message can includea VS marker that provides a notification of the sensed ventricularevent.

At step 928 the rvLP, which is presumed to be the master LP, receivesthe i2i message (transmitted at step 948), and at step 930 the rvLPdetermines an RV-LV delay, which is the delay between when the paced RVevent occurred at step 924 and when the sensed LV event occurred at step946. In accordance with certain embodiments, a time at which a sensedevent is considered to have occurred in the LV chamber is at a peak ofan R-wave or QRS complex detected by lvLP implanted within the LVchamber.

As indicated at step 950 in FIG. 9, steps 902 through 948 are repeated,but pacing occurs in the LV chamber (by the lvLP) and sensing occurs inthe RV chamber (by the rvLP) to thereby determine an LV-RV delay, whichis the delay between when a paced LV event occurs and when a sensed RVevent occurs. In accordance with certain embodiments, a time at which asensed event is considered to have occurred in the RV chamber is at apeak of an R-wave or QRS complex detected by rvLP implanted within theRV chamber.

At step 952 the “correction factor” epsilon (ε) is determined using thefollowing equation:

ε=LV-RV delay−RV-LV delay.

As noted above, in the discussion of step 608 of FIG. 6, the master LPdetermines the VV delay based on the “correction factor” epsilon (ε) aswell as the “delta” (ΔA).

Referring back to the flow diagram of FIG. 6, the determining the P-waveduration at step 602 can occur during a first set of cardiac cycles thatincludes one or more cardiac cycles. If the first set of cardiac cyclesincludes a plurality of cardiac cycles (e.g., 10 cardiac cycles), thenthe P-wave duration can be the mean or median of the P-wave durationsdetermined for the plurality of cardiac cycles.

Referring again to FIG. 8, the determining of the rv PR (or AR) intervalat step 826 can occur during a second set of cardiac cycles thatincludes one or more cardiac cycles. If the second set of cardiac cyclesincludes a plurality of cardiac cycles (e.g., 10 cardiac cycles), thenthe rv PR (or AR) interval can be the mean or median of the rv PR (orAR) intervals determined for the plurality of cardiac cycles. Similarly,the determining of the lv PR (or AR) interval at step 830 can occurduring a third set of cardiac cycles that includes one or more cardiaccycles. If the third set of cardiac cycles includes a plurality ofcardiac cycles (e.g., 10 cardiac cycles), then the lv PR (or AR)interval can be the mean or median of the lv PR (or AR) intervalsdetermined for the plurality of cardiac cycles. Depending uponimplementation, cardiac cycles including in the second and third sets ofcardiac cycles, may, or may not, overlap one another, and may, or maynot, overlap with the first set of cardiac cycles that is used todetermine the P-wave duration.

Referring again to FIG. 9, the pacing the RV chamber and the determiningthe RV-LV delay at steps 924 through 930 can occur during a fourth setof cardiac cycles that includes one or more cardiac cycles. If thefourth set of cardiac cycles includes a plurality of cardiac cycles(e.g., 10 cardiac cycles), then the RV-LV delay determined at step 930can be the mean or median of the RV-LV delays determined for theplurality of cardiac cycles that do not overlap with any of the first,second, and third sets of cardiac cycles. Still referring to FIG. 9, thepacing the LV chamber and the determining the LV-RV delay (as indicatedat step 950) can occur during a fifth set of cardiac cycles include oneor more cardiac cycles that do not overlap with any of the first,second, third, and fourth sets of cardiac cycles.

FIG. 10 is now used to describe certain embodiments in which the raLP,rvLP, and lvLP collectively perform CRT using the AV delay determined atstep 602 and the VV delay determined at step 608. The steps describedwith reference to FIG. 10 can be part of the pacing orchestrated by themaster LP at step 610 in FIG. 6.

Referring to FIG. 10, at step 1002 there is a determination of whetherthe VV delay, that was determined at step 608, is negative. If theanswer to the determination at step 1002 is Yes (i.e., if the VV delayis negative), then flow goes to step 1004. If the answer to thedetermination at step 1002 is No (i.e., if the VV delay is positive),then flow goes to step 1014. Prior to step 1002, or between steps 1002and 1004 (or 1014), the rvLP (e.g., 102 b) determines on its own (e.g.,based on a far-field signal) or based on an i2i message received fromthe raLP (e.g., 102 a), when an atrial paced or sensed event occurs.Similarly, the lvLP (e.g., 102 c) also determines on its own (e.g.,based on a far-field signal or a sensor signal) or based on an i2imessage received from the raLP (e.g., 102 a), when the atrial paced orsensed event occurs.

If the VV delay is negative, then at step 1004 the lvLP paces the LVchamber at the AV delay (determined at step 602) following when theatrial paced or sensed event occurs. Thereafter at step 1006 the rvLPpaces the RV chamber at the VV delay (determined at step 608) followingwhen the lvLP paces the LV chamber (at step 1004). Explained anotherway, at step 1006 the rvLP paces the RV chamber at a delay=AV delay+VVdelay, following when the atrial paced or sensed event occurs. If the VVdelay is positive, then at step 1014 the rvLP paces the RV chamber atthe AV delay (determined at step 602) following when the atrial paced orsensed event occurs. Thereafter, at step 1016, the lvLP paces the LVchamber at the VV delay (determined at step 608) following when the rvLPpaces the RV chamber (at step 1014). Explained another way, at step 1016the lvLP paces the LV chamber at a delay=AV delay+VV delay, followingwhen the atrial paced or sensed event occurs.

In accordance with certain embodiments, following pacing in the RV andLV chambers, by the rvLP and lvLP (e.g., 102 b and 102 c), the raLP(e.g., 102 a) paces the RA chamber at a VA delay following when one ofthe RV or LV chambers is paced. The VA delay that is used by the raLPcan be preprogrammed and fixed, or may be rate dependent, depending onhow the raLP is programmed and/or set. The raLP can determine when theRV and/or LP chambers were paced based on a far-field signal detected bythe raLP (e.g., 102 a), based on a sensor signal (e.g., heart soundsignal) detected by the raLP, or based on one or more transmitted i2imessage the raLP receives from one or both of the rvLP and/or the lvLP(e.g., 102 b and/or 102 c).

FIG. 11 shows a block diagram of showing exemplary further details of anLP 1101 (e.g., 102, 102′, or 102″) that is implanted into the patient aspart of the implantable cardiac system that performs CRT in accordancewith certain embodiments herein. The LP 1101 has a housing 1100 to holdthe electronic/computing components. Housing 1100 (which is oftenreferred to as the “can”, “case”, “encasing”, or “case electrode”) maybe programmably selected to act as the return electrode for certainstimulus modes. Housing 1100 may further include a connector (not shown)with a plurality of terminals 1102, 1104, 1106, 1108, and 1110. Theterminals may be connected to electrodes that are located in variouslocations on housing 1100 or elsewhere within and about the heart. LP1101 includes a programmable microcontroller 1120 that controls variousoperations of LP 1101, including cardiac monitoring and stimulationtherapy. Microcontroller 1120 includes a microprocessor (or equivalentcontrol circuitry), RAM and/or ROM memory, logic and timing circuitry,state machine circuitry, and I/O circuitry. The microcontroller is anexample of a controller (e.g., 112) discussed above.

LP 1101 further includes a pulse generator 1122 that generatesstimulation pulses and communication pulses for delivery by one or moreelectrodes coupled thereto. Pulse generator 1122 is controlled bymicrocontroller 1120 via control signal 1124. Pulse generator 1122 maybe coupled to the select electrode(s) via an electrode configurationswitch 1126, which includes multiple switches for connecting the desiredelectrodes to the appropriate I/O circuits, thereby facilitatingelectrode programmability. Switch 1126 is controlled by a control signal1128 from microcontroller 1120.

In FIG. 11, a single pulse generator 1122 is illustrated. Optionally,the LP may include multiple pulse generators, similar to pulse generator1122, where each pulse generator is coupled to one or more electrodesand controlled by microcontroller 1120 to deliver select stimuluspulse(s) to the corresponding one or more electrodes. For example, onepulse generator can be used to generate pacing pulses, and another pulsegenerator can be used to generate i2i pulses.

Microcontroller 1120 is illustrated as including timing controlcircuitry 1132 to control the timing of the stimulation pulses (e.g.,pacing rate, atrio-ventricular (AV) delay, atrial interconduction (A-A)delay, or ventricular interconduction (V-V) delay, etc.). Timing controlcircuitry 1132 may also be used for the timing of refractory periods,blanking intervals, noise detection windows, evoked response windows,alert intervals, marker channel timing, and so on. Microcontroller 1120may also have an arrhythmia detector 1134 for detecting arrhythmiaconditions and a morphology detector 1136. Although not shown, themicrocontroller 1120 may further include other dedicated circuitryand/or firmware/software components that assist in, monitoring variousconditions of the patient's heart and managing pacing therapies. Themicrocontroller can include a processor. The microcontroller, and/or theprocessor thereof, can be used to perform the methods of the presenttechnology described herein.

LP 1101 is further equipped with a communication modem(modulator/demodulator) 1140 to enable wireless communication with theremote slave pacing unit. Modem 1140 may include one or moretransmitters and one or more receivers as discussed herein in connectionwith FIG. 1B. In one implementation, modem 1140 may use low or highfrequency modulation. As one example, modem 1140 may transmit i2imessages and other signals through conductive communication between apair of electrodes. Modern 1140 may be implemented in hardware as partof microcontroller 1120, or as software/firmware instructions programmedinto and executed by microcontroller 1120. Alternatively, modem 1140 mayreside separately from the microcontroller as a standalone component.

LP 1101 includes a sensing circuit 1144 selectively coupled to one ormore electrodes, that perform sensing operations, through switch 1126 todetect the presence of cardiac activity associated with one or morechambers of the heart. Sensing circuit 1144 may include dedicated senseamplifiers, multiplexed amplifiers, or shared amplifiers. It may furtheremploy one or more low power, precision amplifiers with programmablegain and/or automatic gain control, bandpass filtering, and thresholddetection circuit to selectively sense the cardiac signal of interest.The automatic gain control enables the unit to sense low amplitudesignal characteristics of atrial fibrillation. Switch 1126 determinesthe sensing polarity of the cardiac signal by selectively closing theappropriate switches In this way, the clinician may program the sensingpolarity independent of the stimulation polarity.

The output of sensing circuit 1144 is connected to microcontroller 1120which, in turn, triggers or inhibits the pulse generator 1122 inresponse to the presence or absence of cardiac activity. Sensing circuit1144 receives a control signal 1146 from microcontroller 1120 forpurposes of controlling the gain, threshold, polarization charge removalcircuitry (not shown), and the timing of any blocking circuitry (notshown) coupled to the inputs of the sensing circuitry.

In FIG. 11, a single sensing circuit 1144 is illustrated. Optionally,the LP may include multiple sensing circuits, similar to sensing circuit1144, where each sensing circuit is coupled to one or more electrodesand controlled by microcontroller 1120 to sense electrical activitydetected at the corresponding one or more electrodes. For example, onesensing circuit can be used to sense near-field signals, another sensingcircuit can be used to sense far-field signals, and one or more furthersensing circuits can be used to sense i2i signals.

LP 1101 further includes an analog-to-digital (A/D) data acquisitionsystem (DAS) 1150 coupled to one or more electrodes via switch 1126 tosample cardiac signals across any pair of desired electrodes. Dataacquisition system 1150 is configured to acquire intracardiacelectrogram signals, convert the raw analog data into digital data, andstore the digital data for later processing and/or telemetrictransmission to an external device 1154 (e.g., a programmer, localtransceiver, or a diagnostic system analyzer). Data acquisition system1150 is controlled by a control signal 1156 from the microcontroller1120.

Microcontroller 1120 is coupled to a memory 1160 by a suitabledata/address bus. The programmable operating parameters used bymicrocontroller 1120 are stored in memory 1160 and used to customize theoperation of LP 1101 to suit the needs of a particular patient. Suchoperating parameters define, for example, pacing pulse amplitude, pulseduration, electrode polarity, rate, sensitivity, automatic features,arrhythmia detection criteria, and the amplitude, waveshape and vectorof each shocking pulse to be delivered to the patient's heart withineach respective tier of therapy.

The operating parameters of LP 1101 may be non-invasively programmedinto memory 1160 through a telemetry circuit 1164 in telemetriccommunication via communication link 1166 with external device 1154.Telemetry circuit 1164 allows intracardiac electrograms and statusinformation relating to the operation of LP 1101 (as contained inmicrocontroller 1120 or memory 1160) to be sent to external device 1154through communication link 1166.

LP 1101 can further include magnet detection circuitry (not shown),coupled to microcontroller 1120, to detect when a magnet is placed overthe unit. A magnet may be used by a clinician to perform various testfunctions of LP 1101 and/or to signal microcontroller 1120 that externaldevice 1154 is in place to receive or transmit data to microcontroller1120 through telemetry circuits 1164.

LP 1101 can further include one or more physiological sensors 1170. Suchsensors are commonly referred to as “rate-responsive” sensors becausethey are typically used to adjust pacing stimulation rates according tothe exercise state of the patient. However, physiological sensor 1170may further be used to detect changes in cardiac output, changes in thephysiological condition of the heart, or diurnal changes in activity(e.g., detecting sleep and wake states). Signals generated byphysiological sensors 1170 are passed to microcontroller 1120 foranalysis. Microcontroller 1120 responds by adjusting the various pacingparameters (such as rate, AV Delay, VN Delay, etc.) at which the atrialand ventricular pacing pulses are administered. While shown as beingincluded within LP 1101, physiological sensor(s) 1170 may be external toLP 1101, yet still be implanted within or carried by the patient.Examples of physiologic sensors might include sensors that, for example,sense temperature, respiration rate, pH of blood, ventricular gradient,activity, position/posture, minute ventilation (MV), and so forth. Thephysiological sensors 1170 can include, e.g., an accelerometer (e.g.,154 in FIG. 1B) and/or a pressure sensor (e.g., 156 in FIG. 1B).

A battery 1172 provides operating power to all of the components in LP1101. Battery 1172 is preferably capable of operating at low currentdrains for long periods of time. Battery 1172 also desirably has apredictable discharge characteristic so that elective replacement timecan be detected. As one example, LP 1101 employs a lithium carbonmonofluoride (Li—CFx) battery. In certain embodiments, examples of whichwere described above with reference to FIGS. 9A and 9B, the battery 1172(which was labeled 924 in FIGS. 9A and 9B) can be located in a firsthermetic electrically conductive housing, and the microcontroller 1120and other circuitry can be located in a second hermetic electricallyconductive housing.

LP 1101 further includes an impedance measuring circuit 1174, which canbe used for many things, including: lead impedance surveillance duringthe acute and chronic phases for proper lead positioning ordislodgement; detecting operable electrodes and automatically switchingto an operable pair if dislodgement occurs; measuring respiration orminute ventilation; measuring thoracic impedance for determining shockthresholds; detecting when the device has been implanted; measuringstroke volume; and detecting the opening of heart valves; and so forth.Impedance measuring circuit 1174 is coupled to switch 1126 so that anydesired electrode may be used. In this embodiment LP 1101 furtherincludes a shocking circuit 1180 coupled to microcontroller 1120 by adata/address bus 1182.

187 In some embodiments, an LP is configured to be implantable in anychamber of the heart, namely either atrium (RA, LA) or either ventricle(RV, LV), or alternatively, in a specific cardiac chamber. Certainpacemaker parameters and functions depend on (or assume) knowledge ofthe chamber in which the pacemaker is implanted (and thus with which theLP is interacting; e.g., pacing and/or sensing). Some non-limitingexamples include: sensing sensitivity, an evoked response algorithm, useof AF suppression in a local chamber, blanking & refractory periods,etc. Accordingly, each LP needs to know an identity of the chamber inwhich the LP is implanted, and processes may be implemented toautomatically identify a local chamber associated with each LP.

Processes for chamber identification may also be applied to subcutaneouspacemakers, ICDs, with leads and the like. A device with one or moreimplanted leads, identification and/or confirmation of the chamber intowhich the lead was implanted could be useful in several pertinentscenarios. For example, for a DR or CRT device, automatic identificationand confirmation could mitigate against the possibility of the clinicianinadvertently placing the V lead into the A port of the implantablemedical device, and vice-versa. As another example, for an SR device,automatic identification of implanted chamber could enable the deviceand/or programmer to select and present the proper subset of pacingmodes (e.g., AAI or VVI), and for the IPG to utilize the proper set ofsettings and algorithms (e.g., V-AutoCapture vs ACap-Confirm, sensingsensitivities, etc.).

189 It is to be understood that the subject matter described herein isnot limited in its application to the details of construction and thearrangement of components set forth in the description herein orillustrated in the drawings hereof. The subject matter described hereinis capable of other embodiments and of being practiced or of beingcarried out in various ways. Also, it is to be understood that thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items. Further, it is noted that the term “basedon” as used herein, unless stated otherwise, should be interpreted asmeaning based at least in part on, meaning there can be one or moreadditional factors upon which a decision or the like is made. Forexample, if a decision is based on the results of a comparison, thatdecision can also be based on one or more other factors in addition tobeing based on results of the comparison.

Embodiments of the present technology have been described above with theaid of functional building blocks illustrating the performance ofspecified functions and relationships thereof. The boundaries of thesefunctional building blocks have often been defined herein for theconvenience of the description. Alternate boundaries can be defined solong as the specified functions and relationships thereof areappropriately performed. Any such alternate boundaries are thus withinthe scope and spirit of the claimed invention. For example, it would bepossible to combine or separate some of the steps shown in FIGS. 6-10.For another example, it is possible to change the boundaries of some ofthe dashed blocks shown in FIGS. 1B and 11.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. In addition, many modifications may be made to adapt aparticular situation or material to the teachings of the embodiments ofthe present technology without departing from its scope. While thedimensions, types of materials and coatings described herein areintended to define the parameters of the embodiments of the presenttechnology, they are by no means limiting and are exemplary embodiments.Many other embodiments will be apparent to those of skill in the artupon reviewing the above description. The scope of the embodiments ofthe present technology should, therefore, be determined with referenceto the appended claims, along with the full scope of equivalents towhich such claims are entitled. In the appended claims, the terms“including” and “in which” are used as the plain-English equivalents ofthe respective terms “comprising” and “wherein.” Moreover, in thefollowing claims, the terms “first,” “second,” and “third,” etc. areused merely as labels, and are not intended to impose numericalrequirements on their objects. Further, the limitations of the followingclaims are not written in means—plus-function format and are notintended to be interpreted based on 35 U.S.C. § 112(f), unless and untilsuch claim limitations expressly use the phrase “means for” followed bya statement of function void of further structure.

What is claimed is:
 1. A method for performing cardiac resynchronizationtherapy (CRT) using an implantable leadless pacemaker system including afirst leadless pacemaker (LP1) implanted in or on a right atrial (RA)chamber, a second leadless pacemaker (LP2) implanted in or on a rightventricular (RV) chamber, and a third leadless pacemaker (LP3) implantedin or on a left ventricular (LV) chamber, wherein one of the LP1, theLP2, or the LP3 is designated a master LP, the method comprising: (a)the LP1, which is implanted in or on the RA chamber, measuring a P-waveduration based on a signal sensed by the LP1; (b) the LP1, which isimplanted in or on the RA chamber, or another one of the LPs that isdesignated the master LP, determining an atrio-ventricular (AV) delaybased on the measured P-wave duration; (c) the LP2, which is implantedin or on the RV chamber, or another one of the LPs that is designatedthe master LP, determining a first AR or PR interval indicative of atime between an atrial depolarization and a ventricular depolarizationin the RV chamber; (d) the LP3, which is implanted in or on the LVchamber, or another one of the LPs that is designated the master LP,determining a second AR or PR interval indicative of a time between anatrial depolarization and a ventricular depolarization in the LVchamber; (e) the one of the LPs that is designated the master LPdetermining a delta indicative of a difference between the first AR orPR interval and the second AR or PR interval; (f) the LP2, which isimplanted in or on the RV chamber, pacing the RV chamber, and at leastone of the LPs determining an RV-LV delay indicative of a time it takesfor a ventricular depolarization in the RV chamber to propagate to theLV chamber; (g) the LP3, which is implanted in or on the LV chamber,pacing the LV chamber, and at least one of the LPs determining an LV-RVdelay indicative of a time it takes for a ventricular depolarization inthe LV chamber to propagate to the RV chamber; (h) the one of the LPsthat is designated the master LP determining a correction factorindicative of a difference between the LV-RV delay and the RV-LV delay;(i) the one of the LPs that is designated the master LP determining a VVdelay based on the determined delta and the determined correctionfactor; and (j) the LP1, the LP2, and the LP3 collectively performingCRT using the determined AV delay and the determined VV delay.
 2. Themethod of claim 1, wherein: the measuring the P-wave duration at step(a) occurs during a first set of cardiac cycles comprising one or morecardiac cycles; the determining the first AR or PR interval at step (c)occurs during a second set of cardiac cycles comprising one or morecardiac cycles that may or may not overlap with the first set of cardiaccycles; the determining the second AR or PR interval at step (d) occursduring a third set of cardiac cycles comprising one or more cardiaccycles that may or may not overlap with the first and/or second set ofcardiac cycles; the pacing the RV chamber and the determining the RV-LVdelay at step (f) occurs during a fourth set of cardiac cyclescomprising one or more cardiac cycles that do not overlap with any ofthe first, second, and third sets of cardiac cycles; and the pacing theLV chamber and the determining the LV-RV delay at step (g) occurs duringa fifth set of cardiac cycles comprising one or more cardiac cycles thatdo not overlap with any of the first, second, third, and fourth sets ofcardiac cycles.
 3. The method of claim 1, wherein when the AV delay isfor use in pacing during one or more cardiac cycles that start with anintrinsic atrial event, the determining the AV delay based on themeasured P-wave duration, comprises: setting the AV delay to the P-waveduration plus a first offset, in response to the P-wave duration beinggreater than a threshold duration; and setting the AV delay to theP-wave duration plus a second offset that is greater than the firstoffset, in response to the P-wave duration being less than the thresholdduration.
 4. The method of claim 3, wherein when the AV delay is for usein pacing during one or more cardiac cycles that start with a pacedatrial event, the determining the AV delay based on the measured P-waveduration, comprises: setting the AV delay to the P-wave duration plus athird offset, in response to the P-wave duration being greater than asecond threshold duration; and setting the AV delay to the P-waveduration plus a fourth offset that is greater than the third offset, inresponse to the P-wave duration being less than the second thresholdduration.
 5. The method of claim 1, wherein at step (i) the one of theLPs that is designated the master LP determining the VV delay based onthe determined delta and the determined correction factor, comprises:the one of the LPs that is designated the master LP determining the VVdelay as being equal to half of a sum of the determined delta plus thedetermined correction factor.
 6. The method of claim 1, wherein at step(j) the LP1, the LP2, and the LP3 collectively performing CRT using thedetermined AV delay and the determined VV delay, comprises: the LP2,determining on its own or based on an i2i message received from the LP1,when an atrial paced or sensed event occurs; and the LP3, determining onits own or based on an i2i message received from the LP1, when theatrial paced or sensed event occurs; if the VV delay is negative, thenthe LP3 pacing the LV chamber at the AV delay following when the atrialpaced or sensed event occurs, and then the LP2 pacing the RV chamber atthe VV delay following when the LP3 paces the LV chamber; and if the VVdelay is positive, then the LP2 pacing the RV chamber at the AV delayfollowing when the atrial paced or sensed event occurs, and then the LP3pacing the LV chamber at the VV delay following when the LP2 paces theRV chamber.
 7. The method of claim 1, wherein at step (j) the LP1, theLP2, and the LP3 collectively performing CRT using the determined AVdelay and the determined VV delay, comprises: the LP2, determining onits own or based on an i2i message received from the LP1, when an atrialpaced or sensed event occurs; and the LP3, determining on its own orbased on an i2i message received from the LP1, when the atrial paced orsensed event occurs; if the VV delay is negative, then the LP3 pacingthe LV chamber at the AV delay following when the atrial paced or sensedevent occurs, and then the LP2 pacing the RV chamber at a delay equal toa sum of the AV delay plus the VV delay following when the atrial pacedor sensed event occurs; and if the VV delay is positive, then the LP2pacing the RV chamber at the AV delay following when the atrial paced orsensed event occurs, and then the LP3 pacing the LV chamber at the delayequal to a sum of the AV delay plus the VV delay following when theatrial paced or sensed event occurs.
 8. The method of claim 1, whereinat step (j) the LP1, the LP2, and the LP3 collectively performing CRT,using the determined AV delay and the determined VV delay, isorchestrated by the one of the LPs that is designated the master LP. 9.The method of claim 1, wherein at step (j) the LP1, the LP2, and the LP3collectively performing CRT, includes the LP1 pacing the RA chamber at aVA delay following when the LP2 paced the RV chamber or the LP3 pacedthe LV chamber.
 10. The method of claim 1, wherein the LP2, which isimplanted in or on the RV chamber, is designated the master LP.
 11. Animplantable system for performing cardiac resynchronization therapy(CRT), comprising: a first leadless pacemaker (LP1) configured to beimplanted in or on a right atrial (RA) chamber and selectively pace theRA chamber; a second leadless pacemaker (LP2) configured to be implantedin or on a right ventricular (RV) chamber and selectively pace the RVchamber; a third leadless pacemaker (LP3) configured to be implanted inor on a left ventricular (LV) chamber and selectively pace the LVchamber; one of the LP1, the LP2, or the LP3 designated a master LP; theLP1 also configured to sense a signal and measure a P-wave durationbased on the signal sensed by the LP1; the LPI, or another one of theLPs that is designated the master LP, configured to determine anatrio-ventricular (AV) delay based on the measured P-wave duration; theLP2, or another one of the LPs that is designated the master LP,configured to determine a first AR or PR interval indicative of a timebetween an atrial depolarization and a ventricular depolarization in theRV chamber; the LP3, or another one of the LPs that is designated themaster LP, configured to determine a second AR or PR interval indicativeof a time between an atrial depolarization and a ventriculardepolarization in the LV chamber; at least one of the LPs configured todetermine an RV-LV delay indicative of a time it takes for a ventriculardepolarization in the RV chamber to propagate to the LV chamber inresponse to the LP2 pacing the RV chamber; at east one of the LPsconfigured to determine an LV-RV delay indicative of a time it takes fora ventricular depolarization in the LV chamber to propagate to the RVchamber in response to the LP3 pacing the LV chamber; and the one of theLPs that is designated the master LP configured to determine a deltaindicative of a difference between the first AR or PR interval and thesecond AR or PR interval, determine a correction factor indicative of adifference between the LV-RV delay and the RV-LV delay, and determine aVV delay based on the determined delta and the determined correctionfactor; wherein the LP1, the LP2, and the LP3 are configured tocollectively perform CRT using the determined AV delay and thedetermined VV delay.
 12. The system of claim 11, wherein: the LP1, whichis configured to be implanted in or on the RA chamber, is configured tomeasure the P-wave duration during a first set of cardiac cyclescomprising one or more cardiac cycles; the LP2, which is configured tobe implanted in or on the RV chamber, is configured to determine thefirst AR or PR interval during a second set of cardiac cycles comprisingone or more cardiac cycles that may or may not overlap with the firstset of cardiac cycles; the LP3, which is configured to be implanted inor on the LV chamber, is configured to determine the second AR or PRinterval during a third set of cardiac cycles comprising one or morecardiac cycles that may or may not overlap with the first and/or secondset of cardiac cycles; the LP2 is also configured to determine the RV-LVdelay during a fourth set of cardiac cycles comprising one or morecardiac cycles that do not overlap with any of the first, second, andthird sets of cardiac cycles; and the LP3 is also configured todetermine the LV-RV delay during a fifth set of cardiac cyclescomprising one or more cardiac cycles that do not overlap with any ofthe first, second, third, and fourth sets of cardiac cycles.
 13. Thesystem of claim 11, wherein when the AV delay is for use in pacingduring one or more cardiac cycles that start with an intrinsic atrialevent, the LP that is designated the master is configured to: set the AVdelay to the P-wave duration plus a first offset, in response to theP-wave duration being greater than a threshold duration; and set the AVdelay to the P-wave duration plus a second offset that is greater thanthe first offset, in response to the P-wave duration being less than thethreshold duration.
 14. The system of claim 13, wherein when the AVdelay is for use in pacing during one or more cardiac cycles that startwith a paced atrial event, the LP that is designated the master isconfigured to: set the AV delay to the P-wave duration plus a thirdoffset, in response to the P-wave duration being greater than a secondthreshold duration; and set the AV delay to the P-wave duration plus afourth offset that is greater than the third offset, in response to theP-wave duration being less than the second threshold duration.
 15. Thesystem of claim 11, wherein the LP that is designated the master LP isconfigured to determine the VV delay as being equal to half of a sum ofthe determined delta plus the determined correction factor.
 16. Thesystem of claim 11, wherein the LP1, the LP2, and the LP3 are configuredto collectively performing CRT using the determined AV delay and thedetermined VV delay, and wherein: the LP2 is configured to determine onits own or based on an i2i message received from the LP1, when an atrialpaced or sensed event occurs; and the LP3 is configured to determine onits own or based on an i2i message received from the LP1, when theatrial paced or sensed event occurs; when the VV delay is negative, theLP3 is configured to pace the LV chamber at the AV delay following whenthe atrial paced or sensed event occurs, and the LP2 is configured topace the RV chamber at the VV delay following when the LP3 paces the LVchamber; and when the VV delay is positive, the LP2 is configured topace the RV chamber at the AV delay following when the atrial paced orsensed event occurs, and the LP3 is configured to pace the LV chamber atthe VV delay following when the LP2 paces the RV chamber.
 17. The systemof claim 11, wherein the LP1, the LP2, and the LP3 are configured tocollectively performing CRT using the determined AV delay and thedetermined VV delay, and wherein: the LP2, which is configured to beimplanted in or on the RV chamber, is configured to determine on its ownor based on an i2i message received from the LP1, when an atrial pacedor sensed event occurs; and the LP3, which is configured to be implantedin or on the LV chamber, is configured to determine on its own or basedon an i2i message received from the LP1, when the atrial paced or sensedevent occurs; when the VV delay is negative, the LP3 is configured topace the LV chamber at the AV delay following when the atrial paced orsensed event occurs, and the LP2 is configured to pace the RV chamber ata delay equal to a sum of the AV delay plus the VV delay following whenthe atrial paced or sensed event occurs; and when the VV delay ispositive, the LP2 is configured to pace the RV chamber at the AV delayfollowing when the atrial paced or sensed event occurs, and the LP3 isconfigured to pace the LV chamber at the delay equal to a sum of the AVdelay plus the VV delay following when the atrial paced or sensed eventoccurs.
 18. The system of claim 11, the one of the LPs that isdesignated the master LP is configured to orchestrate the CRT that iscollectively performed by the LP1, the LP2, and the LP3 using thedetermined AV delay and the determined VV delay.
 19. The system of claim11, wherein the LP1, which is configured to be implanted in or on the RAchamber, is configured to pace the RA chamber at a VA delay followingwhen the LP2 paces the RV chamber or the LP3 paces the LV chamber. 20.The system of claim 11, wherein the LP2, which is configured to beimplanted in or on the RV chamber, is designated the master LP.
 21. Aleadless pacemaker (rvLP) configured to be implanted in or on a rightventricular (RV) chamber and configured to perform cardiacresynchronization therapy (CRT) along with a leadless pacemaker (raLP)configured to be implanted in or on a right atrial (RA) chamber and aleadless pacemaker (lvLP) configured to be implanted in or on a leftventricular (LV) chamber, the rvLP comprising: one or more pulsegenerators configured to selectively produce pacing pulses andimplant-to-implant (i2i) communication pulses, the pacing pulses for usein pacing the RV chamber, and the i2i communication pulses for use insending i2i messages to at least one of the raLP or the lvLP; aplurality of electrodes at least two of which can be used to deliver oneor more pacing pulses to the RV chamber, at least two of which can beused to transmit and receive one or more i2i communication pulses to andfrom at least one of the raLP or the lvLP, and at least two of which canbe used to sense a far-field signal from which cardiac activityassociated with at least one of the RA or LV chambers may be detected;and a controller configured to determine an atrio-ventricular (AV) delaybased on a P-wave duration measurement received via one or more i2icommunication pulses from the raLP; an RV-LV delay indicative of a timeit takes for a ventricular depolarization in the RV chamber to propagateto the LV chamber in response to the rvLP pacing the RV chamber; anLV-RV delay indicative of a time it takes for a ventriculardepolarization in the LV chamber to propagate to the RV chamber inresponse to the lvLP pacing the LV chamber; a delta indicative of adifference between a first AR or PR interval and a second AR or PRinterval, the first AR or PR interval indicative of a time between anatrial depolarization and a ventricular depolarization in the RVchamber, and the second AR or PR interval indicative of a time betweenan atrial depolarization and a ventricular depolarization in the LVchamber; a correction factor indicative of a difference between theLV-RV delay and the RV-LV delay; and a VV delay based on the determineddelta and the determined correction factor; the controller alsoconfigured to coordinate performance of CRT collectively by the rvLP,raLP, and lvLP using the determined AV delay and the determined VVdelay.